Intramuscular midazolam versus intravenous diazepam for treatment of seizures in the pediatric emergency department: A randomized clinical trial

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Roraima, Prédio 22, Campus, Bairro Camobi, Zip Code: 97105 900, Santa Maria, RS, Brazil" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "School of Medicine, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, RS, Brazil" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Department of Pediatrics, School of Medicine, PUCRS, Brazil" "etiqueta" => "c" "identificador" => "aff0015" ] 3 => array:3 [ "entidad" => "Hospital São Lucas, PUCRS, Porto Alegre, RS, Brazil" "etiqueta" => "d" "identificador" => "aff0020" ] 4 => array:3 [ "entidad" => "Department of Pediatrics, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Brazil" "etiqueta" => "e" "identificador" => "aff0025" ] 5 => array:3 [ "entidad" => "Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil" "etiqueta" => "f" "identificador" => "aff0030" ] 6 => array:3 [ "entidad" => "Pediatric Emergency Department, Hospital Universitário de Santa Maria, UFSM, Brazil" "etiqueta" => "g" "identificador" => "aff0035" ] 7 => array:3 [ "entidad" => "Pediatric Intensive Care Locum Consultant, Addenbrooke's Hospital, Cambridge, UK" "etiqueta" => "h" "identificador" => "aff0040" ] 8 => array:3 [ "entidad" => "Pediatric NeuroCritical Care Program, CHMC, Boston, USA" "etiqueta" => "i" "identificador" => "aff0045" ] 9 => array:3 [ "entidad" => "Harvard Medical School, USA" "etiqueta" => "j" "identificador" => "aff0050" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Midazolam intramuscular frente a diazepam intravenoso para el tratamiento de convulsiones en el Servicio de Urgencias Pediátricas: ensayo clínico aleatorizado" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 676 "Ancho" => 1417 "Tamanyo" => 62337 ] ] "descripcion" => array:1 [ "en" => "Study flowchart." ] ] ] "textoCompleto" => "IntroductionBackgroundEpileptic seizures are a common cause of pediatric emergency department visits. The vast majority of seizures cease within 5min; however, some are prolonged and may progress to status epilepticus (SE).<a class="elsevierStyleCrossRef" href="#bib0005">1</a> SE, defined as continuous or recurring seizure activity lasting longer than 30min, is associated with major morbidity rate and carries a mortality rate of up to 20%.<a class="elsevierStyleCrossRef" href="#bib0010">2</a> Prolonged seizure activity leads to failure of cerebral autoregulation, which consequently reduces cerebral blood flow and eventually results in cerebral hypoxia.<a class="elsevierStyleCrossRefs" href="#bib0010">2,3</a>ImportanceBenzodiazepines (BZDs) have been used in the urgent care of seizures for over 40 years, and are considered first-line therapy for this purpose. The BZDs, which act on GABAA receptors, are effective in the treatment of various types of seizure, have a rapid onset of action after intravenous administration, excellent penetration into the central nervous system, and a good safety profile. Persistent generalized seizure activity increases benzodiazepine resistance; therefore, there is a consensus as to the need for immediate treatment of seizures.<a class="elsevierStyleCrossRefs" href="#bib0010">2,4–8</a> Lorazepam, diazepam, and midazolam are the three BZDs used in this setting. Lorazepam is the drug of choice due to its rapid onset of action and prolonged effect, but no parenteral formulations are available in Brazil. Consequently, intravenous diazepam, which provides seizure control in 85–90% of the cases,<a class="elsevierStyleCrossRefs" href="#bib0010">2,3</a> is the first-line drug of choice for acute treatment of seizures in Brazilian practice.Goals of this investigationWhen venous access is challenging or cannot be obtained, the most common alternatives have been rectal diazepam and intranasal midazolam, with some studies suggesting intramuscular midazolam as an additional option.<a class="elsevierStyleCrossRefs" href="#bib0035">7,9</a> The difficulty of administering BZDs rectally or intranasally and the erratic absorption provided by these routes jeopardize anticonvulsant efficacy.<a class="elsevierStyleCrossRefs" href="#bib0025">5,6,8,10–13</a> Median time to achievement of intravenous access in children ranges from 5 to 7min.<a class="elsevierStyleCrossRefs" href="#bib0040">8,11</a> Difficulties in obtaining venous access delay treatment and, consequently, increase the risk of progression to status epilepticus. Thus far, no consensus has been established as to the best route for administration of BZDs in the event of failed intravenous access.<a class="elsevierStyleCrossRefs" href="#bib0005">1,5</a>The objective of this study was to compare the therapeutic efficacy of intramuscular midazolam (MDZ-IM) with that of intravenous diazepam (DZP-IV) in children admitted to the referral service of a pediatric emergency department with epileptic seizures.Patients and methodsStudy design and settingThis randomized clinical trial was carried out between August 2010 and August 2011 in a sample of children admitted to the pediatric emergency department of Santa Maria University Hospital (PSPed-HUSM) with epileptic seizures. PSPed is a tertiary referral center in Southern Brazil, staffed by dedicated pediatricians and pediatric residents, which treats approximately 4000 pediatric patients per month. The study was approved by the local Research Ethics Committee (protocol no. 0184.0.243.000-10) in accordance with the Declaration of Helsinki 1964 revised in 2008. In view of the nature of the study condition and to provide the best possible benefit in this urgent setting, the committee authorized immediate patient allocation and treatment without prior consent. Subjects’ parents or legal guardians were then notified of the trial, and those who agreed to the use of patient data for research purposes were asked to provide written informed consent.The study protocol was presented by the authors and approved by the medical officers and nursing staff of the department, who received specific training in its use.Selection of participantsInclusion criteria: children between the ages of 2 months and 14 years who were admitted to the emergency department with seizures, regardless of type or potential trigger, and in whom anticonvulsant medication was indicated and ordered by the attending physician. Children could be enrolled in the study more than once.Exclusion criteria: children in whom venous access had been obtained in the prehospital setting and those with a known history of coagulopathy or hepatic and/or renal impairment.InterventionsPatients admitted to the pediatric emergency department with seizures were randomly allocated to one of the two treatment groups: (a) Intravenous diazepam (DZP-IV), 0.5mg/kg IV (maximum dose 10mg) at a concentration of 5mg/ml and with an application speed of 5mg/min, or (b) intramuscular midazolam (MDZ-IM), 0.5mg/kg IM (maximum dose 15mg) at a concentration of 5mg/ml.Patients were randomized in blocks of 10. Five slips of paper marked “DZP-IV” and five slips marked “MDZ-IM” were placed into a brown paper envelope. At the time of admission, the nurse in charge of medication administration took a slip of paper from the envelope at random and administered the corresponding drug as standardized in the study protocol, after adjusting the dose for weight and age.Methods and measurementsIdentifying information and physiological parameters were recorded. The following variables were used as outcome measures: time from admission to drug administration (including time required to obtain intravenous access), time from drug administration to cessation of seizures, and total time from admission to cessation of seizures.Heart rate and pulse oximetry were monitored in all patients throughout treatment. Vital signs were recorded on admission and every 5min thereafter until discharge or transfer. Airway suctioning, supplemental oxygen, or tracheal intubation were provided as necessary or when ordered by the attending physician. Immediate adverse drug reactions were assessed in the first 10min after administration of MDZ-IM or DZP-IV. The emergency department where the study was performed is equipped with crash carts containing all the necessary equipment and medications for treatment of cardiorespiratory instability.Outcomes and analysisTreatment was considered successful when cessation of seizures was achieved within 5min of administration of a single dose of study drug (DZP or MDZ). Requirement of a second dose of study drug or additional medications was defined as treatment failure.Inability to obtain venous access within 4min was defined as “failed intravenous access.” This 4-min cutoff was chosen on the basis of mean time to establish intravenous access by Pediatric Emergency nursing staff during emergency care.Statistical analysis: continuous variables were expressed as means and standard deviations. Comparisons were performed using Student's t-test (for normally distributed variables) or the Mann–Whitney U test (in case of wide variability). Categorical variables were expressed as percentages and comparisons were performed with the chi-square or Fisher's exact tests.ResultsCharacteristics of study subjectsOf the 180 children admitted to the Pediatric Emergency Department at Santa Maria University Hospital (Brazil) with a chief complaint of convulsive seizures, 144 were postictal on arrival. The remaining 36 children were enrolled in the study. Of these, 16 were allocated to the MDZ-IM group and 20 to the DZP-IV group. All children allocated to the midazolam group completed the study. Of those allocated to the diazepam arm, four (20%) were excluded due to failed intravenous access, and the remaining 16 completed the study (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>). The parents or guardians of all 32 children who completed the study had provided informed consent for participation.<elsevierMultimedia ident="fig0005"></elsevierMultimedia>There were no significant between-group differences in age, weight, sex, seizure etiology, vital signs, or blood glucose levels on admission. In both groups, most children were under the age of 5 (<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>).<elsevierMultimedia ident="tbl0005"></elsevierMultimedia>Main resultsIn 14 patients in each group (87.5%), seizure activity ceased after administration of a single BZD dose, which shows that both intramuscular midazolam and intravenous diazepam are effective anticonvulsants. Two patients in each group (12.5%) required a second dose of study drug or additional medications for seizure control (treatment failure).In the MDZ-IM group, active treatment was instituted significantly sooner than in the DZP-IV group (2.8 versus 7.4min; p=0.001). Total time to cessation of seizures was also significantly shorter in the MZD-IM group (time between admission and seizure cessation, 7.3 versus 10.6min; p=0.006) (<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>). However, time from drug administration to cessation of seizures was significantly shorter in the DZP-IV group (3.3 versus 4.4min; p=0.001).<elsevierMultimedia ident="tbl0010"></elsevierMultimedia>As noted above, two patients in each group (12.5%) were considered to have failed treatment due to persistence of seizures more than 5min after BZD administration. The between-group differences in time to active treatment and time to cessation of seizures held true regardless of inclusion or exclusion of the patients that failed treatment (<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>).All children in both groups exhibited cyanosis and psychomotor agitation on admission and required supplemental oxygen by nasal cannula or non-rebreather mask. One child in the DZP-IV group progressed to SE of 40-min duration, requiring phenytoin for seizure control, and one child had a seizure duration of 6min, requiring only an additional dose of IV diazepam. In the MDZ-IM group, one child had a seizure lasting 10min, requiring intravenous diazepam and phenytoin. Additionally, one child in the MDZ group had SE that lasted 55min and did not respond to intravenous diazepam. In this case, cessation was achieved after rectal diazepam and an additional dose of intramuscular midazolam.One child (6.25%) in the MDZ group required intubation, artificial ventilation, and ICU admission due to respiratory failure on admission to the ED (SaO2=64%). Two children (12.5%) in the DZP group required intubation and ICU admission (one due to severe head trauma and one due to respiratory failure with SaO2=80%).All children were monitored until cessation of seizures or discharge. There were no significant between-group differences in vital signs (<a class="elsevierStyleCrossRef" href="#fig0010">Fig. 2</a>).<elsevierMultimedia ident="fig0010"></elsevierMultimedia>Possible immediate adverse drug reactions (those occurring within 10min of study drug administration) included hypotension in one child (6.3%) in the MDZ-IM group, two children (12.6%) with hyperactivity and salivation, one (6.3%) with nausea, and two (12.6%) with vomiting in the DZP-IV group. Nevertheless, the between-group difference in adverse reactions did not reach statistical significance (<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>).DiscussionIn this randomized clinical trial where intramuscular midazolam was compared with intravenous diazepam for treatment of seizures in the pediatric emergency department, the following findings were observed: (a) in a reasonably high percentage of patients (20%), intravenous access cannot be achieved within 5min of admission; (b) time from admission to active treatment and time from admission to cessation of seizures are significantly shorter with IM midazolam; and, the previous finding notwithstanding, (c) time from drug administration to cessation of seizures is significantly shorter with IV diazepam instead of IM midazolam.Current treatment protocols propose that all children with convulsive seizures of >5-min duration should be managed according to established treatment algorithms for status epilepticus, in view of the complications and risk of neurological damage associated with prolonged seizure activity.<a class="elsevierStyleCrossRef" href="#bib0030">6</a> The first 10min of management should focus on protecting the airway and maintaining its patency, providing supplemental oxygen, measuring blood glucose, obtaining intravenous access, and treating the seizure with an intravenous benzodiazepine.<a class="elsevierStyleCrossRefs" href="#bib0015">3,6,8</a>One may presume that the minimum time required for a child to reach the emergency department after the onset of seizures, when transported from the home by parents, is 5min. Studies have estimated that at least 5–7min are required to obtain intravenous access in pediatric patients.<a class="elsevierStyleCrossRefs" href="#bib0040">8,11</a> The sum of these times means at least 10–12min will have elapsed between seizure onset and active treatment, which increases the risk of complications.When intravenous access cannot be obtained, buccal or intranasal administration of midazolam has been advocated, with an effectiveness rate in the region of 60%.<a class="elsevierStyleCrossRef" href="#bib0065">13</a> Despite good absorption through the mucous membranes of the mouth and nose, administration of midazolam through these routes can be extraordinarily challenging due to the involuntary movements of the convulsing child and due to the presence of airway secretion, which impedes proper absorption.<a class="elsevierStyleCrossRefs" href="#bib0010">2,13</a> Rectal administration of diazepam is associated with erratic absorption and poor therapeutic success rates (27%).<a class="elsevierStyleCrossRefs" href="#bib0020">4,12</a>Midazolam has been used in the treatment of seizures since the 1980s,<a class="elsevierStyleCrossRef" href="#bib0070">14</a> with a good safety profile in terms of respiratory depression and good absorption via several routes (intranasal, buccal, rectal, and intramuscular).<a class="elsevierStyleCrossRefs" href="#bib0065">13,15–17</a> A study conducted in pediatric emergency departments in Australia and New Zealand showed that, when venous access could not be obtained, 49% of the physicians used rectal diazepam and 41% used intramuscular midazolam, which shows increasing preference for the intramuscular route.<a class="elsevierStyleCrossRef" href="#bib0090">18</a>As in previous studies, IV diazepam has a faster onset of action than IM midazolam after administration (3.3min versus 4.4min), due to the shorter time to peak serum levels and, consequently, earlier achievement of therapeutic levels in the CNS.<a class="elsevierStyleCrossRefs" href="#bib0005">1,11,19</a> Nevertheless, actual time to cessation of seizures (i.e. time from admission to the emergency department to cessation of seizure activity) was significantly shorter in the IM midazolam group (7.3min versus 10.6min), which corroborates the observations of a similar trial.<a class="elsevierStyleCrossRef" href="#bib0100">20</a>These results suggest that, when treating children with convulsive seizures in whom venous access is expected to be difficult or unlikely, IM administration of midazolam is safe, effective, and perhaps superior to intravenous diazepam. It bears stressing that seizure duration is directly associated with the speed of benzodiazepine administration.<a class="elsevierStyleCrossRef" href="#bib0025">5</a> Similar findings have been reported in the treatment of behavioral disturbances in adult patients (where intravenous access is also challenging), where IM administration was superior to IV sedation in terms of time to cessation of psychomotor agitation (21min versus 30min).<a class="elsevierStyleCrossRef" href="#bib0105">21</a> Therefore, even though BZDs act more rapidly when administered by the intravenous route, early intramuscular administration of midazolam provides superior therapeutic efficacy, due to faster administration as well as due to the excellent absorption of midazolam by this route.Failed intravenous access is widely recognized as a hindrance to implementation of urgent care protocols in the pediatric emergency department. It is estimated that 2.5–16min are required to obtain peripheral venous access in adults, with a failure rate of 10–40%. In children, this rate ranges from 14% to 70%, with failure being most common in infants.<a class="elsevierStyleCrossRefs" href="#bib0055">11,22–24</a> Venous access could not be obtained in 20% of the 20 children randomized to the DZP-IV arm of this study, which provides further evidence of the importance of intramuscular administration of anticonvulsants in this setting.Adverse effects were more frequent in the diazepam group, as expected in view of previous comparisons with midazolam and lorazepam,<a class="elsevierStyleCrossRefs" href="#bib0045">9,19</a> although the difference did not reach statistical significance. The adverse effects of BZDs are usually dose-dependent and associated with repeated administration, and manifest most commonly as reduced oxygen saturation and central hypoventilation.<a class="elsevierStyleCrossRefs" href="#bib0010">2,5</a> These findings are rapidly reversed with administration of supplemental oxygen, airway suctioning and positional maneuvers and, in a minority of cases, bag-valve-mask ventilation.The etiology of seizures varies according to age and geographical region. However, most studies report that approximately one-third of children admitted to an emergency department with convulsions are having a febrile seizure,<a class="elsevierStyleCrossRefs" href="#bib0125">25–27</a> as was the case in the present study.One limitation of this study is that the sample size precludes any conclusions about adverse effects and drug safety, which would require a larger population. Furthermore, due to the design and nature of the study, personnel in charge of administering drugs were not blinded to allocation, which may have introduced bias. Despite this limitation, the times to seizure cessation obtained in this study were highly favorable, especially in view of the study setting (the dedicated pediatric emergency department of a large, university-affiliated tertiary care center). One may presume that at smaller hospitals, where staff might have less skill or experience obtaining intravenous access in children, the difference would be even more significant.Another limitation of the present study is the fact that, although the cause of seizure could be initially identified at the emergency room in most patients, this initial identification does reach a 100% level of certainty. Therefore, emergency room professionals may have failed to identify, at first, a child with an underlying neurological disease leading to unresponsiveness to seizure treatment.The results of the study suggest that intramuscular midazolam significantly shortens seizure duration in children as compared with intravenous diazepam. Therefore, intramuscular midazolam is a good alternative to intravenous diazepam, in view of its anticonvulsant efficacy and speed and ease of administration in the pediatric emergency care setting.Conflicts of interestThe authors have no conflicts of interest to declare.Authors’ contributionAll authors took part in data collection and analysis, literature review, and drafting of the manuscript." "textoCompletoSecciones" => array:1 [ "secciones" => array:11 [ 0 => array:3 [ "identificador" => "xres475183" "titulo" => "Abstract" "secciones" => array:7 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Aim" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Design" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Setting" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Intervention" ] 4 => array:2 [ "identificador" => "abst0025" "titulo" => "Main measurements" ] 5 => array:2 [ "identificador" => "abst0030" "titulo" => "Results" ] 6 => array:2 [ "identificador" => "abst0035" "titulo" => "Conclusion" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec497264" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres475184" "titulo" => "Resumen" "secciones" => array:8 [ 0 => array:2 [ "identificador" => "abst0040" "titulo" => "Objetivo" ] 1 => array:2 [ "identificador" => "abst0045" "titulo" => "Diseño" ] 2 => array:2 [ "identificador" => "abst0050" "titulo" => "Ámbito" ] 3 => array:2 [ "identificador" => "abst0055" "titulo" => "Pacientes" ] 4 => array:2 [ "identificador" => "abst0060" "titulo" => "Intervención" ] 5 => array:2 [ "identificador" => "abst0065" "titulo" => "Mediciones principales" ] 6 => array:2 [ "identificador" => "abst0070" "titulo" => "Resultados" ] 7 => array:2 [ "identificador" => "abst0075" "titulo" => "Conclusión" ] ] ] 3 => array:2 [ "identificador" => "xpalclavsec497263" "titulo" => "Palabras clave" ] 4 => array:3 [ "identificador" => "sec0005" "titulo" => "Introduction" "secciones" => array:3 [ 0 => array:2 [ "identificador" => "sec0010" "titulo" => "Background" ] 1 => array:2 [ "identificador" => "sec0015" "titulo" => "Importance" ] 2 => array:2 [ "identificador" => "sec0020" "titulo" => "Goals of this investigation" ] ] ] 5 => array:3 [ "identificador" => "sec0025" "titulo" => "Patients and methods" "secciones" => array:5 [ 0 => array:2 [ "identificador" => "sec0030" "titulo" => "Study design and setting" ] 1 => array:2 [ "identificador" => "sec0035" "titulo" => "Selection of participants" ] 2 => array:2 [ "identificador" => "sec0040" "titulo" => "Interventions" ] 3 => array:2 [ "identificador" => "sec0045" "titulo" => "Methods and measurements" ] 4 => array:2 [ "identificador" => "sec0050" "titulo" => "Outcomes and analysis" ] ] ] 6 => array:3 [ "identificador" => "sec0055" "titulo" => "Results" "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0060" "titulo" => "Characteristics of study subjects" ] 1 => array:2 [ "identificador" => "sec0065" "titulo" => "Main results" ] ] ] 7 => array:2 [ "identificador" => "sec0070" "titulo" => "Discussion" ] 8 => array:2 [ "identificador" => "sec0075" "titulo" => "Conflicts of interest" ] 9 => array:2 [ "identificador" => "sec0080" "titulo" => "Authors’ contribution" ] 10 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2013-12-09" "fechaAceptado" => "2014-04-03" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec497264" "palabras" => array:4 [ 0 => "Seizures" 1 => "Benzodiazepines" 2 => "Status epilepticus" 3 => "Epilepsy" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec497263" "palabras" => array:4 [ 0 => "Convulsiones" 1 => "Benzodiazepínicos" 2 => "Estado epiléptico" 3 => "Epilepsia" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:3 [ "titulo" => "Abstract" "resumen" => "AimTo compare the therapeutic efficacy of intramuscular midazolam (MDZ-IM) with that of intravenous diazepam (DZP-IV) for seizures in children. DesignRandomized clinical trial. SettingPediatric emergency department.Patients: Children aged 2 months to 14 years admitted to the study facility with seizures. InterventionPatients were randomized to receive DZP-IV or MDZ-IM. Main measurementsGroups were compared with respect to time to treatment start (min), time from drug administration to seizure cessation (min), time to seizure cessation (min), and rate of treatment failure. Treatment was considered successful when seizure cessation was achieved within 5min of drug administration. ResultsOverall, 32 children (16 per group) completed the study. Intravenous access could not be obtained within 5min in four patients (25%) in the DZP-IV group. Time from admission to active treatment and time to seizure cessation was shorter in the MDZ-IM group (2.8 versus 7.4min; p<0.001 and 7.3 versus 10.6min; p=0.006, respectively). In two children per group (12.5%), seizures continued after 10min of treatment, and additional medications were required. There were no between-group differences in physiological parameters or adverse events (p=0.171); one child (6.3%) developed hypotension in the MDZ-IM group and five (31%) developed hyperactivity or vomiting in the DZP-IV group. ConclusionGiven its efficacy and ease and speed of administration, intramuscular midazolam is an excellent option for treatment of childhood seizures, enabling earlier treatment and shortening overall seizure duration. There were no differences in complications when applying MDZ-IM or DZP-IV." "secciones" => array:7 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Aim" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Design" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Setting" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Intervention" ] 4 => array:2 [ "identificador" => "abst0025" "titulo" => "Main measurements" ] 5 => array:2 [ "identificador" => "abst0030" "titulo" => "Results" ] 6 => array:2 [ "identificador" => "abst0035" "titulo" => "Conclusion" ] ] ] "es" => array:3 [ "titulo" => "Resumen" "resumen" => "ObjetivoComparar la eficacia de midazolam intramuscular (MDZ-IM) con la de diazepam intravenoso (DZP-IV) para convulsiones en niños. DiseñoEnsayo clínico aleatorizado. ÁmbitoServicio de Urgencias Pediátricas. PacientesNiños de entre 2 meses y 14 años internados con convulsiones. IntervenciónLos pacientes fueron aleatorizados para recibir DZP-IV o MDZ-IM. Mediciones principalesTiempo hasta el inicio del tratamiento (minutos), tiempo entre la administración del medicamento y el cese de la convulsión (minutos), tiempo hasta el cese de la convulsión (minutos), y tasa de fallo del tratamiento. El tratamiento fue considerado exitoso cuando las convulsiones cesaron en los 5min tras la administración del medicamento. ResultadosCompletaron el estudio 32 niños (16 por grupo). No fue posible obtener acceso intravenoso en 4 pacientes (25%) del grupo DZP-IV. El tiempo entre la internación y el tratamiento fue menor en el grupo MDZ-IM (2,8 vs. 7,4 min; p<0,001), así como el tiempo hasta el cese de la convulsión (7,3 vs. 10,6 min; p=0,006). En 2 niños de cada grupo (12,5%), las convulsiones continuaron después de 10min de tratamiento. No hubo diferencias entre los grupos en los parámetros fisiológicos o eventos adversos (p=0,171); un niño (6,3%) del grupo MDZ-IM presentó hipotensión, y 5 del grupo DZP-IV (31%) presentaron hiperactividad o vómitos. ConclusiónDada su eficacia, facilidad y velocidad de administración, MDZ-IM es una excelente opción para el tratamiento de convulsiones infantiles, posibilitando un tratamiento precoz y reduciendo la duración de la convulsión. No hubo diferencias en las complicaciones al aplicar MDZ-IM o DZP-IV." "secciones" => array:8 [ 0 => array:2 [ "identificador" => "abst0040" "titulo" => "Objetivo" ] 1 => array:2 [ "identificador" => "abst0045" "titulo" => "Diseño" ] 2 => array:2 [ "identificador" => "abst0050" "titulo" => "Ámbito" ] 3 => array:2 [ "identificador" => "abst0055" "titulo" => "Pacientes" ] 4 => array:2 [ "identificador" => "abst0060" "titulo" => "Intervención" ] 5 => array:2 [ "identificador" => "abst0065" "titulo" => "Mediciones principales" ] 6 => array:2 [ "identificador" => "abst0070" "titulo" => "Resultados" ] 7 => array:2 [ "identificador" => "abst0075" "titulo" => "Conclusión" ] ] ] ] "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "Work center: Pediatric Emergency Department, Hospital Universitário de Santa Maria Universidade Federal de Santa Maria (UFSM), Av. Roraima, Prédio 22, Campus, Bairro Camobi, Zip Code: 97105-900 – Santa Maria, RS, Brazil." ] ] "multimedia" => array:4 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 676 "Ancho" => 1417 "Tamanyo" => 62337 ] ] "descripcion" => array:1 [ "en" => "Study flowchart." ] ] 1 => array:7 [ "identificador" => "fig0010" "etiqueta" => "Figure 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 2057 "Ancho" => 2493 "Tamanyo" => 300163 ] ] "descripcion" => array:1 [ "en" => "Vital signs (systolic and diastolic blood pressure, heart rate, respiratory rate) of children in the IM midazolam and IV diazepam groups, at 5min, 10min, and discharge or transfer." ] ] 2 => array:7 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "tabla" => array:2 [ "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head " align="" valign="top" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Intramuscular midazolam(n=16) \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Intravenous diazepam(n=16) \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">p \t\t\t\t\t\t\n \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Age (months) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">46.4±53.1 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">45.0±49.2 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">0.451<a class="elsevierStyleCrossRef" href="#tblfn0005">*</a> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Median (range) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">13.9 (10.7–70.0) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">14.3 (4.4–90.8) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="" valign="top"> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="4" align="left" valign="top"></td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Weight (kg) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">15.9±10.6 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">17.7±13.0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">1.000<a class="elsevierStyleCrossRef" href="#tblfn0005">*</a> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Median (range) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">11.5 (8.1–19.2) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">13.2 (7.2–26.5) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="" valign="top"> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="4" align="left" valign="top"></td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Male sex, n (%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">12 (75.0%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">8 (50.0%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">0.273<a class="elsevierStyleCrossRef" href="#tblfn0010">†</a> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Systolic blood pressure (mmHg) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">99.5±21.6 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">102.0±16.4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">0.715<a class="elsevierStyleCrossRef" href="#tblfn0015">‡</a> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Diastolic blood pressure (mmHg) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">61.6±16.1 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">63.4±12.6 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">0.735<a class="elsevierStyleCrossRef" href="#tblfn0015">‡</a> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Body temperature (°C) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">37.3±1.4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">37.0±1.4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">0.670<a class="elsevierStyleCrossRef" href="#tblfn0015">‡</a> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Heart rate (bpm) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">149.2±29.0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">137.6±31.6 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">0.289<a class="elsevierStyleCrossRef" href="#tblfn0015">‡</a> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Respiratory rate (bpm) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">37.0±16.5 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">37.1±9.7 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">0.985<a class="elsevierStyleCrossRef" href="#tblfn0015">‡</a> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Oxygen saturation (%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">90.9±8.7 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">90.4±5.3 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">0.846<a class="elsevierStyleCrossRef" href="#tblfn0015">‡</a> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Blood glucose (mg/dL) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">116.6±51.6 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">116.8±39.1 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">0.955<a class="elsevierStyleCrossRef" href="#tblfn0005">*</a> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Age<5 years, n (%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">12 (75.0%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">10 (62.5%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">0.702<a class="elsevierStyleCrossRef" href="#tblfn0010">†</a> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Febrile seizures, n (%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">7 (43.7%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">6 (37.5%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">0.718<a class="elsevierStyleCrossRef" href="#tblfn0010">†</a> \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab748346.png" ] ] ] "notaPie" => array:3 [ 0 => array:3 [ "identificador" => "tblfn0005" "etiqueta" => "*" "nota" => "Non-normal continuous variables (Mann–Whitney U)." ] 1 => array:3 [ "identificador" => "tblfn0010" "etiqueta" => "†" "nota" => "Categorical variables (chi-square or Fisher's exact tests)." ] 2 => array:3 [ "identificador" => "tblfn0015" "etiqueta" => "‡" "nota" => "Normally distributed continuous variables (Student's t-test)." ] ] ] "descripcion" => array:1 [ "en" => "Sample profile by group." ] ] 3 => array:7 [ "identificador" => "tbl0010" "etiqueta" => "Table 2" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "tabla" => array:3 [ "leyenda" => "DZP-IV, intravenous diazepam; ICU, intensive care unit; MDZ-IM, intramuscular midazolam." "tablatextoimagen" => array:2 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Per-protocol analysis (treatment success only) \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">MDZ-IM(n=14) \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">DZP-IV(n=14) \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">p \t\t\t\t\t\t\n \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Time from admission to active treatment (min) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">2.8±1.5 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">7.4±4.1 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">0.001<a class="elsevierStyleCrossRef" href="#tblfn0030">‡</a> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Time from active treatment to cessation of seizures (min) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">4.4±0.5 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">3.3±0.8 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top"><0.001<a class="elsevierStyleCrossRef" href="#tblfn0030">‡</a> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Time from admission to cessation of seizures (min) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">7.3±1.4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">10.6±3.9 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">0.006<a class="elsevierStyleCrossRef" href="#tblfn0030">‡</a> \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab748345.png" ] ] 1 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Intention-to-treat analysis (including treatment failures) \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">MDZ-IM(n=16) \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">DZP-IV(n=16) \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">p \t\t\t\t\t\t\n \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Time from admission to active treatment (min) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">3.8±2.8 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">7.4±4.0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">0.001<a class="elsevierStyleCrossRef" href="#tblfn0020">*</a> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Time from active treatment to cessation of seizures (min) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">7.9±12.6 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">5.7±9.1 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">0.003<a class="elsevierStyleCrossRef" href="#tblfn0020">*</a> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Time from admission to cessation of seizures (min) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">11.7±14.6 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">13.1±10.5 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">0.007<a class="elsevierStyleCrossRef" href="#tblfn0020">*</a> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Failed intravenous access (n, %) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="" valign="top"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">4 (25%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">0.0001<a class="elsevierStyleCrossRef" href="#tblfn0025">†</a> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Treatment failure (n, %) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">2 (12.5%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">2 (12.5%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">1.000<a class="elsevierStyleCrossRef" href="#tblfn0025">†</a> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">ICU transfer (n, %) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">1 (6.25%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">2 (12.5%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">1.000<a class="elsevierStyleCrossRef" href="#tblfn0025">†</a> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Adverse drug reactions (n, %) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">1 (6.3%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">5 (31%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">0.171<a class="elsevierStyleCrossRef" href="#tblfn0025">†</a> \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab748344.png" ] ] ] "notaPie" => array:3 [ 0 => array:3 [ "identificador" 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Intramuscular midazolam versus intravenous diazepam for treatment of seizures in the pediatric emergency department: A randomized clinical trial

Midazolam intramuscular frente a diazepam intravenoso para el tratamiento de convulsiones en el Servicio de Urgencias Pediátricas: ensayo clínico aleatorizado

J.L. Portelaa,b, P.C.R. Garciac,d,

Corresponding author

celiny@pucrs.br
celiny@terra.com.br

Corresponding author.

, J.P. Pivae,f, A. Barcelosb,g, F. Brunoc,d, R. Brancoh, R.C. Taskeri,j

a Pediatric Emergency Department, Hospital Universitário de Santa Maria, Universidade Federal de Santa Maria (UFSM), Av. Roraima, Prédio 22, Campus, Bairro Camobi, Zip Code: 97105 900, Santa Maria, RS, Brazil

b School of Medicine, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, RS, Brazil

c Department of Pediatrics, School of Medicine, PUCRS, Brazil

d Hospital São Lucas, PUCRS, Porto Alegre, RS, Brazil

e Department of Pediatrics, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Brazil

f Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil

g Pediatric Emergency Department, Hospital Universitário de Santa Maria, UFSM, Brazil

h Pediatric Intensive Care Locum Consultant, Addenbrooke's Hospital, Cambridge, UK

i Pediatric NeuroCritical Care Program, CHMC, Boston, USA

j Harvard Medical School, USA

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        "titulo" => "Midazolam intramuscular frente a diazepam intravenoso para el tratamiento de convulsiones en el Servicio de Urgencias Pedi&#225;tricas&#58; ensayo cl&#237;nico aleatorizado"
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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Introduction</span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Background</span><p id="par0005" class="elsevierStylePara elsevierViewall">Epileptic seizures are a common cause of pediatric emergency department visits&#46; The vast majority of seizures cease within 5<span class="elsevierStyleHsp" style=""></span>min&#59; however&#44; some are prolonged and may progress to status epilepticus &#40;SE&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> SE&#44; defined as continuous or recurring seizure activity lasting longer than 30<span class="elsevierStyleHsp" style=""></span>min&#44; is associated with major morbidity rate and carries a mortality rate of up to 20&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> Prolonged seizure activity leads to failure of cerebral autoregulation&#44; which consequently reduces cerebral blood flow and eventually results in cerebral hypoxia&#46;<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2&#44;3</span></a></p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Importance</span><p id="par0010" class="elsevierStylePara elsevierViewall">Benzodiazepines &#40;BZDs&#41; have been used in the urgent care of seizures for over 40 years&#44; and are considered first-line therapy for this purpose&#46; The BZDs&#44; which act on GABA<span class="elsevierStyleInf">A</span> receptors&#44; are effective in the treatment of various types of seizure&#44; have a rapid onset of action after intravenous administration&#44; excellent penetration into the central nervous system&#44; and a good safety profile&#46; Persistent generalized seizure activity increases benzodiazepine resistance&#59; therefore&#44; there is a consensus as to the need for immediate treatment of seizures&#46;<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2&#44;4&#8211;8</span></a> Lorazepam&#44; diazepam&#44; and midazolam are the three BZDs used in this setting&#46; Lorazepam is the drug of choice due to its rapid onset of action and prolonged effect&#44; but no parenteral formulations are available in Brazil&#46; Consequently&#44; intravenous diazepam&#44; which provides seizure control in 85&#8211;90&#37; of the cases&#44;<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2&#44;3</span></a> is the first-line drug of choice for acute treatment of seizures in Brazilian practice&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Goals of this investigation</span><p id="par0015" class="elsevierStylePara elsevierViewall">When venous access is challenging or cannot be obtained&#44; the most common alternatives have been rectal diazepam and intranasal midazolam&#44; with some studies suggesting intramuscular midazolam as an additional option&#46;<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">7&#44;9</span></a> The difficulty of administering BZDs rectally or intranasally and the erratic absorption provided by these routes jeopardize anticonvulsant efficacy&#46;<a class="elsevierStyleCrossRefs" href="#bib0025"><span class="elsevierStyleSup">5&#44;6&#44;8&#44;10&#8211;13</span></a> Median time to achievement of intravenous access in children ranges from 5 to 7<span class="elsevierStyleHsp" style=""></span>min&#46;<a class="elsevierStyleCrossRefs" href="#bib0040"><span class="elsevierStyleSup">8&#44;11</span></a> Difficulties in obtaining venous access delay treatment and&#44; consequently&#44; increase the risk of progression to status epilepticus&#46; Thus far&#44; no consensus has been established as to the best route for administration of BZDs in the event of failed intravenous access&#46;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#44;5</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">The objective of this study was to compare the therapeutic efficacy of intramuscular midazolam &#40;MDZ-IM&#41; with that of intravenous diazepam &#40;DZP-IV&#41; in children admitted to the referral service of a pediatric emergency department with epileptic seizures&#46;</p></span></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Patients and methods</span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Study design and setting</span><p id="par0025" class="elsevierStylePara elsevierViewall">This randomized clinical trial was carried out between August 2010 and August 2011 in a sample of children admitted to the pediatric emergency department of Santa Maria University Hospital &#40;PSPed-HUSM&#41; with epileptic seizures&#46; PSPed is a tertiary referral center in Southern Brazil&#44; staffed by dedicated pediatricians and pediatric residents&#44; which treats approximately 4000 pediatric patients per month&#46; The study was approved by the local Research Ethics Committee &#40;protocol no&#46; 0184&#46;0&#46;243&#46;000-10&#41; in accordance with the Declaration of Helsinki 1964 revised in 2008&#46; In view of the nature of the study condition and to provide the best possible benefit in this urgent setting&#44; the committee authorized immediate patient allocation and treatment without prior consent&#46; Subjects&#8217; parents or legal guardians were then notified of the trial&#44; and those who agreed to the use of patient data for research purposes were asked to provide written informed consent&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">The study protocol was presented by the authors and approved by the medical officers and nursing staff of the department&#44; who received specific training in its use&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Selection of participants</span><p id="par0035" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Inclusion criteria&#58;</span> children between the ages of 2 months and 14 years who were admitted to the emergency department with seizures&#44; regardless of type or potential trigger&#44; and in whom anticonvulsant medication was indicated and ordered by the attending physician&#46; Children could be enrolled in the study more than once&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Exclusion criteria&#58;</span> children in whom venous access had been obtained in the prehospital setting and those with a known history of coagulopathy or hepatic and&#47;or renal impairment&#46;</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0135">Interventions</span><p id="par0045" class="elsevierStylePara elsevierViewall">Patients admitted to the pediatric emergency department with seizures were randomly allocated to one of the two treatment groups&#58; &#40;a&#41; Intravenous diazepam &#40;DZP-IV&#41;&#44; 0&#46;5<span class="elsevierStyleHsp" style=""></span>mg&#47;kg IV &#40;maximum dose 10<span class="elsevierStyleHsp" style=""></span>mg&#41; at a concentration of 5<span class="elsevierStyleHsp" style=""></span>mg&#47;ml and with an application speed of 5<span class="elsevierStyleHsp" style=""></span>mg&#47;min&#44; or &#40;b&#41; intramuscular midazolam &#40;MDZ-IM&#41;&#44; 0&#46;5<span class="elsevierStyleHsp" style=""></span>mg&#47;kg IM &#40;maximum dose 15<span class="elsevierStyleHsp" style=""></span>mg&#41; at a concentration of 5<span class="elsevierStyleHsp" style=""></span>mg&#47;ml&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">Patients were randomized in blocks of 10&#46; Five slips of paper marked &#8220;DZP-IV&#8221; and five slips marked &#8220;MDZ-IM&#8221; were placed into a brown paper envelope&#46; At the time of admission&#44; the nurse in charge of medication administration took a slip of paper from the envelope at random and administered the corresponding drug as standardized in the study protocol&#44; after adjusting the dose for weight and age&#46;</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0140">Methods and measurements</span><p id="par0055" class="elsevierStylePara elsevierViewall">Identifying information and physiological parameters were recorded&#46; The following variables were used as outcome measures&#58; time from admission to drug administration &#40;including time required to obtain intravenous access&#41;&#44; time from drug administration to cessation of seizures&#44; and total time from admission to cessation of seizures&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">Heart rate and pulse oximetry were monitored in all patients throughout treatment&#46; Vital signs were recorded on admission and every 5<span class="elsevierStyleHsp" style=""></span>min thereafter until discharge or transfer&#46; Airway suctioning&#44; supplemental oxygen&#44; or tracheal intubation were provided as necessary or when ordered by the attending physician&#46; Immediate adverse drug reactions were assessed in the first 10<span class="elsevierStyleHsp" style=""></span>min after administration of MDZ-IM or DZP-IV&#46; The emergency department where the study was performed is equipped with crash carts containing all the necessary equipment and medications for treatment of cardiorespiratory instability&#46;</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0145">Outcomes and analysis</span><p id="par0065" class="elsevierStylePara elsevierViewall">Treatment was considered successful when cessation of seizures was achieved within 5<span class="elsevierStyleHsp" style=""></span>min of administration of a single dose of study drug &#40;DZP or MDZ&#41;&#46; Requirement of a second dose of study drug or additional medications was defined as treatment failure&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">Inability to obtain venous access within 4<span class="elsevierStyleHsp" style=""></span>min was defined as &#8220;failed intravenous access&#46;&#8221; This 4-min cutoff was chosen on the basis of mean time to establish intravenous access by Pediatric Emergency nursing staff during emergency care&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Statistical analysis&#58;</span> continuous variables were expressed as means and standard deviations&#46; Comparisons were performed using Student&#39;s <span class="elsevierStyleItalic">t</span>-test &#40;for normally distributed variables&#41; or the Mann&#8211;Whitney <span class="elsevierStyleItalic">U</span> test &#40;in case of wide variability&#41;&#46; Categorical variables were expressed as percentages and comparisons were performed with the chi-square or Fisher&#39;s exact tests&#46;</p></span></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0150">Results</span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0155">Characteristics of study subjects</span><p id="par0080" class="elsevierStylePara elsevierViewall">Of the 180 children admitted to the Pediatric Emergency Department at Santa Maria University Hospital &#40;Brazil&#41; with a chief complaint of convulsive seizures&#44; 144 were postictal on arrival&#46; The remaining 36 children were enrolled in the study&#46; Of these&#44; 16 were allocated to the MDZ-IM group and 20 to the DZP-IV group&#46; All children allocated to the midazolam group completed the study&#46; Of those allocated to the diazepam arm&#44; four &#40;20&#37;&#41; were excluded due to failed intravenous access&#44; and the remaining 16 completed the study &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#41;&#46; The parents or guardians of all 32 children who completed the study had provided informed consent for participation&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0085" class="elsevierStylePara elsevierViewall">There were no significant between-group differences in age&#44; weight&#44; sex&#44; seizure etiology&#44; vital signs&#44; or blood glucose levels on admission&#46; In both groups&#44; most children were under the age of 5 &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0160">Main results</span><p id="par0090" class="elsevierStylePara elsevierViewall">In 14 patients in each group &#40;87&#46;5&#37;&#41;&#44; seizure activity ceased after administration of a single BZD dose&#44; which shows that both intramuscular midazolam and intravenous diazepam are effective anticonvulsants&#46; Two patients in each group &#40;12&#46;5&#37;&#41; required a second dose of study drug or additional medications for seizure control &#40;treatment failure&#41;&#46;</p><p id="par0095" class="elsevierStylePara elsevierViewall">In the MDZ-IM group&#44; active treatment was instituted significantly sooner than in the DZP-IV group &#40;2&#46;8 versus 7&#46;4<span class="elsevierStyleHsp" style=""></span>min&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;001&#41;&#46; Total time to cessation of seizures was also significantly shorter in the MZD-IM group &#40;time between admission and seizure cessation&#44; 7&#46;3 versus 10&#46;6<span class="elsevierStyleHsp" style=""></span>min&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;006&#41; &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#41;&#46; However&#44; time from drug administration to cessation of seizures was significantly shorter in the DZP-IV group &#40;3&#46;3 versus 4&#46;4<span class="elsevierStyleHsp" style=""></span>min&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;001&#41;&#46;</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><p id="par0100" class="elsevierStylePara elsevierViewall">As noted above&#44; two patients in each group &#40;12&#46;5&#37;&#41; were considered to have failed treatment due to persistence of seizures more than 5<span class="elsevierStyleHsp" style=""></span>min after BZD administration&#46; The between-group differences in time to active treatment and time to cessation of seizures held true regardless of inclusion or exclusion of the patients that failed treatment &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#41;&#46;</p><p id="par0105" class="elsevierStylePara elsevierViewall">All children in both groups exhibited cyanosis and psychomotor agitation on admission and required supplemental oxygen by nasal cannula or non-rebreather mask&#46; One child in the DZP-IV group progressed to SE of 40-min duration&#44; requiring phenytoin for seizure control&#44; and one child had a seizure duration of 6<span class="elsevierStyleHsp" style=""></span>min&#44; requiring only an additional dose of IV diazepam&#46; In the MDZ-IM group&#44; one child had a seizure lasting 10<span class="elsevierStyleHsp" style=""></span>min&#44; requiring intravenous diazepam and phenytoin&#46; Additionally&#44; one child in the MDZ group had SE that lasted 55<span class="elsevierStyleHsp" style=""></span>min and did not respond to intravenous diazepam&#46; In this case&#44; cessation was achieved after rectal diazepam and an additional dose of intramuscular midazolam&#46;</p><p id="par0110" class="elsevierStylePara elsevierViewall">One child &#40;6&#46;25&#37;&#41; in the MDZ group required intubation&#44; artificial ventilation&#44; and ICU admission due to respiratory failure on admission to the ED &#40;SaO<span class="elsevierStyleInf">2</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>64&#37;&#41;&#46; Two children &#40;12&#46;5&#37;&#41; in the DZP group required intubation and ICU admission &#40;one due to severe head trauma and one due to respiratory failure with SaO<span class="elsevierStyleInf">2</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>80&#37;&#41;&#46;</p><p id="par0115" class="elsevierStylePara elsevierViewall">All children were monitored until cessation of seizures or discharge&#46; There were no significant between-group differences in vital signs &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>&#41;&#46;</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0120" class="elsevierStylePara elsevierViewall">Possible immediate adverse drug reactions &#40;those occurring within 10<span class="elsevierStyleHsp" style=""></span>min of study drug administration&#41; included hypotension in one child &#40;6&#46;3&#37;&#41; in the MDZ-IM group&#44; two children &#40;12&#46;6&#37;&#41; with hyperactivity and salivation&#44; one &#40;6&#46;3&#37;&#41; with nausea&#44; and two &#40;12&#46;6&#37;&#41; with vomiting in the DZP-IV group&#46; Nevertheless&#44; the between-group difference in adverse reactions did not reach statistical significance &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#41;&#46;</p></span></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0165">Discussion</span><p id="par0125" class="elsevierStylePara elsevierViewall">In this randomized clinical trial where intramuscular midazolam was compared with intravenous diazepam for treatment of seizures in the pediatric emergency department&#44; the following findings were observed&#58; &#40;a&#41; in a reasonably high percentage of patients &#40;20&#37;&#41;&#44; intravenous access cannot be achieved within 5<span class="elsevierStyleHsp" style=""></span>min of admission&#59; &#40;b&#41; time from admission to active treatment and time from admission to cessation of seizures are significantly shorter with IM midazolam&#59; and&#44; the previous finding notwithstanding&#44; &#40;c&#41; time from drug administration to cessation of seizures is significantly shorter with IV diazepam instead of IM midazolam&#46;</p><p id="par0130" class="elsevierStylePara elsevierViewall">Current treatment protocols propose that all children with convulsive seizures of &#62;5-min duration should be managed according to established treatment algorithms for status epilepticus&#44; in view of the complications and risk of neurological damage associated with prolonged seizure activity&#46;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> The first 10<span class="elsevierStyleHsp" style=""></span>min of management should focus on protecting the airway and maintaining its patency&#44; providing supplemental oxygen&#44; measuring blood glucose&#44; obtaining intravenous access&#44; and treating the seizure with an intravenous benzodiazepine&#46;<a class="elsevierStyleCrossRefs" href="#bib0015"><span class="elsevierStyleSup">3&#44;6&#44;8</span></a></p><p id="par0135" class="elsevierStylePara elsevierViewall">One may presume that the minimum time required for a child to reach the emergency department after the onset of seizures&#44; when transported from the home by parents&#44; is 5<span class="elsevierStyleHsp" style=""></span>min&#46; Studies have estimated that at least 5&#8211;7<span class="elsevierStyleHsp" style=""></span>min are required to obtain intravenous access in pediatric patients&#46;<a class="elsevierStyleCrossRefs" href="#bib0040"><span class="elsevierStyleSup">8&#44;11</span></a> The sum of these times means at least 10&#8211;12<span class="elsevierStyleHsp" style=""></span>min will have elapsed between seizure onset and active treatment&#44; which increases the risk of complications&#46;</p><p id="par0140" class="elsevierStylePara elsevierViewall">When intravenous access cannot be obtained&#44; buccal or intranasal administration of midazolam has been advocated&#44; with an effectiveness rate in the region of 60&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a> Despite good absorption through the mucous membranes of the mouth and nose&#44; administration of midazolam through these routes can be extraordinarily challenging due to the involuntary movements of the convulsing child and due to the presence of airway secretion&#44; which impedes proper absorption&#46;<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2&#44;13</span></a> Rectal administration of diazepam is associated with erratic absorption and poor therapeutic success rates &#40;27&#37;&#41;&#46;<a class="elsevierStyleCrossRefs" href="#bib0020"><span class="elsevierStyleSup">4&#44;12</span></a></p><p id="par0145" class="elsevierStylePara elsevierViewall">Midazolam has been used in the treatment of seizures since the 1980s&#44;<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">14</span></a> with a good safety profile in terms of respiratory depression and good absorption via several routes &#40;intranasal&#44; buccal&#44; rectal&#44; and intramuscular&#41;&#46;<a class="elsevierStyleCrossRefs" href="#bib0065"><span class="elsevierStyleSup">13&#44;15&#8211;17</span></a> A study conducted in pediatric emergency departments in Australia and New Zealand showed that&#44; when venous access could not be obtained&#44; 49&#37; of the physicians used rectal diazepam and 41&#37; used intramuscular midazolam&#44; which shows increasing preference for the intramuscular route&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">18</span></a></p><p id="par0150" class="elsevierStylePara elsevierViewall">As in previous studies&#44; IV diazepam has a faster onset of action than IM midazolam after administration &#40;3&#46;3<span class="elsevierStyleHsp" style=""></span>min versus 4&#46;4<span class="elsevierStyleHsp" style=""></span>min&#41;&#44; due to the shorter time to peak serum levels and&#44; consequently&#44; earlier achievement of therapeutic levels in the CNS&#46;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#44;11&#44;19</span></a> Nevertheless&#44; actual time to cessation of seizures &#40;i&#46;e&#46; time from admission to the emergency department to cessation of seizure activity&#41; was significantly shorter in the IM midazolam group &#40;7&#46;3<span class="elsevierStyleHsp" style=""></span>min versus 10&#46;6<span class="elsevierStyleHsp" style=""></span>min&#41;&#44; which corroborates the observations of a similar trial&#46;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">20</span></a></p><p id="par0155" class="elsevierStylePara elsevierViewall">These results suggest that&#44; when treating children with convulsive seizures in whom venous access is expected to be difficult or unlikely&#44; IM administration of midazolam is safe&#44; effective&#44; and perhaps superior to intravenous diazepam&#46; It bears stressing that seizure duration is directly associated with the speed of benzodiazepine administration&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> Similar findings have been reported in the treatment of behavioral disturbances in adult patients &#40;where intravenous access is also challenging&#41;&#44; where IM administration was superior to IV sedation in terms of time to cessation of psychomotor agitation &#40;21<span class="elsevierStyleHsp" style=""></span>min versus 30<span class="elsevierStyleHsp" style=""></span>min&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">21</span></a> Therefore&#44; even though BZDs act more rapidly when administered by the intravenous route&#44; early intramuscular administration of midazolam provides superior therapeutic efficacy&#44; due to faster administration as well as due to the excellent absorption of midazolam by this route&#46;</p><p id="par0160" class="elsevierStylePara elsevierViewall">Failed intravenous access is widely recognized as a hindrance to implementation of urgent care protocols in the pediatric emergency department&#46; It is estimated that 2&#46;5&#8211;16<span class="elsevierStyleHsp" style=""></span>min are required to obtain peripheral venous access in adults&#44; with a failure rate of 10&#8211;40&#37;&#46; In children&#44; this rate ranges from 14&#37; to 70&#37;&#44; with failure being most common in infants&#46;<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">11&#44;22&#8211;24</span></a> Venous access could not be obtained in 20&#37; of the 20 children randomized to the DZP-IV arm of this study&#44; which provides further evidence of the importance of intramuscular administration of anticonvulsants in this setting&#46;</p><p id="par0165" class="elsevierStylePara elsevierViewall">Adverse effects were more frequent in the diazepam group&#44; as expected in view of previous comparisons with midazolam and lorazepam&#44;<a class="elsevierStyleCrossRefs" href="#bib0045"><span class="elsevierStyleSup">9&#44;19</span></a> although the difference did not reach statistical significance&#46; The adverse effects of BZDs are usually dose-dependent and associated with repeated administration&#44; and manifest most commonly as reduced oxygen saturation and central hypoventilation&#46;<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2&#44;5</span></a> These findings are rapidly reversed with administration of supplemental oxygen&#44; airway suctioning and positional maneuvers and&#44; in a minority of cases&#44; bag-valve-mask ventilation&#46;</p><p id="par0170" class="elsevierStylePara elsevierViewall">The etiology of seizures varies according to age and geographical region&#46; However&#44; most studies report that approximately one-third of children admitted to an emergency department with convulsions are having a febrile seizure&#44;<a class="elsevierStyleCrossRefs" href="#bib0125"><span class="elsevierStyleSup">25&#8211;27</span></a> as was the case in the present study&#46;</p><p id="par0175" class="elsevierStylePara elsevierViewall">One limitation of this study is that the sample size precludes any conclusions about adverse effects and drug safety&#44; which would require a larger population&#46; Furthermore&#44; due to the design and nature of the study&#44; personnel in charge of administering drugs were not blinded to allocation&#44; which may have introduced bias&#46; Despite this limitation&#44; the times to seizure cessation obtained in this study were highly favorable&#44; especially in view of the study setting &#40;the dedicated pediatric emergency department of a large&#44; university-affiliated tertiary care center&#41;&#46; One may presume that at smaller hospitals&#44; where staff might have less skill or experience obtaining intravenous access in children&#44; the difference would be even more significant&#46;</p><p id="par0180" class="elsevierStylePara elsevierViewall">Another limitation of the present study is the fact that&#44; although the cause of seizure could be initially identified at the emergency room in most patients&#44; this initial identification does reach a 100&#37; level of certainty&#46; Therefore&#44; emergency room professionals may have failed to identify&#44; at first&#44; a child with an underlying neurological disease leading to unresponsiveness to seizure treatment&#46;</p><p id="par0185" class="elsevierStylePara elsevierViewall">The results of the study suggest that intramuscular midazolam significantly shortens seizure duration in children as compared with intravenous diazepam&#46; Therefore&#44; intramuscular midazolam is a good alternative to intravenous diazepam&#44; in view of its anticonvulsant efficacy and speed and ease of administration in the pediatric emergency care setting&#46;</p></span><span id="sec0075" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0170">Conflicts of interest</span><p id="par0190" class="elsevierStylePara elsevierViewall">The authors have no conflicts of interest to declare&#46;</p></span><span id="sec0080" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0175">Authors&#8217; contribution</span><p id="par0195" class="elsevierStylePara elsevierViewall">All authors took part in data collection and analysis&#44; literature review&#44; and drafting of the manuscript&#46;</p></span></span>"
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        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Aim</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">To compare the therapeutic efficacy of intramuscular midazolam &#40;MDZ-IM&#41; with that of intravenous diazepam &#40;DZP-IV&#41; for seizures in children&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Design</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Randomized clinical trial&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Setting</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Pediatric emergency department&#46;</p><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Patients&#58; Children aged 2 months to 14 years admitted to the study facility with seizures&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Intervention</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Patients were randomized to receive DZP-IV or MDZ-IM&#46;</p></span> <span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Main measurements</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Groups were compared with respect to time to treatment start &#40;min&#41;&#44; time from drug administration to seizure cessation &#40;min&#41;&#44; time to seizure cessation &#40;min&#41;&#44; and rate of treatment failure&#46; Treatment was considered successful when seizure cessation was achieved within 5<span class="elsevierStyleHsp" style=""></span>min of drug administration&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Results</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Overall&#44; 32 children &#40;16 per group&#41; completed the study&#46; Intravenous access could not be obtained within 5<span class="elsevierStyleHsp" style=""></span>min in four patients &#40;25&#37;&#41; in the DZP-IV group&#46; Time from admission to active treatment and time to seizure cessation was shorter in the MDZ-IM group &#40;2&#46;8 versus 7&#46;4<span class="elsevierStyleHsp" style=""></span>min&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;001 and 7&#46;3 versus 10&#46;6<span class="elsevierStyleHsp" style=""></span>min&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;006&#44; respectively&#41;&#46; In two children per group &#40;12&#46;5&#37;&#41;&#44; seizures continued after 10<span class="elsevierStyleHsp" style=""></span>min of treatment&#44; and additional medications were required&#46; There were no between-group differences in physiological parameters or adverse events &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;171&#41;&#59; one child &#40;6&#46;3&#37;&#41; developed hypotension in the MDZ-IM group and five &#40;31&#37;&#41; developed hyperactivity or vomiting in the DZP-IV group&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Conclusion</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Given its efficacy and ease and speed of administration&#44; intramuscular midazolam is an excellent option for treatment of childhood seizures&#44; enabling earlier treatment and shortening overall seizure duration&#46; There were no differences in complications when applying MDZ-IM or DZP-IV&#46;</p></span>"
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        "resumen" => "<span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Objetivo</span><p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Comparar la eficacia de midazolam intramuscular &#40;MDZ-IM&#41; con la de diazepam intravenoso &#40;DZP-IV&#41; para convulsiones en ni&#241;os&#46;</p></span> <span id="abst0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Dise&#241;o</span><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">Ensayo cl&#237;nico aleatorizado&#46;</p></span> <span id="abst0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0060">&#193;mbito</span><p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">Servicio de Urgencias Pedi&#225;tricas&#46;</p></span> <span id="abst0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Pacientes</span><p id="spar0060" class="elsevierStyleSimplePara elsevierViewall">Ni&#241;os de entre 2 meses y 14 a&#241;os internados con convulsiones&#46;</p></span> <span id="abst0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Intervenci&#243;n</span><p id="spar0065" class="elsevierStyleSimplePara elsevierViewall">Los pacientes fueron aleatorizados para recibir DZP-IV o MDZ-IM&#46;</p></span> <span id="abst0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Mediciones principales</span><p id="spar0070" class="elsevierStyleSimplePara elsevierViewall">Tiempo hasta el inicio del tratamiento &#40;minutos&#41;&#44; tiempo entre la administraci&#243;n del medicamento y el cese de la convulsi&#243;n &#40;minutos&#41;&#44; tiempo hasta el cese de la convulsi&#243;n &#40;minutos&#41;&#44; y tasa de fallo del tratamiento&#46; El tratamiento fue considerado exitoso cuando las convulsiones cesaron en los 5<span class="elsevierStyleHsp" style=""></span>min tras la administraci&#243;n del medicamento&#46;</p></span> <span id="abst0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Resultados</span><p id="spar0075" class="elsevierStyleSimplePara elsevierViewall">Completaron el estudio 32 ni&#241;os &#40;16 por grupo&#41;&#46; No fue posible obtener acceso intravenoso en 4 pacientes &#40;25&#37;&#41; del grupo DZP-IV&#46; El tiempo entre la internaci&#243;n y el tratamiento fue menor en el grupo MDZ-IM &#40;2&#44;8 vs&#46; 7&#44;4 min&#59; p<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#44;001&#41;&#44; as&#237; como el tiempo hasta el cese de la convulsi&#243;n &#40;7&#44;3 vs&#46; 10&#44;6 min&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;006&#41;&#46; En 2 ni&#241;os de cada grupo &#40;12&#44;5&#37;&#41;&#44; las convulsiones continuaron despu&#233;s de 10<span class="elsevierStyleHsp" style=""></span>min de tratamiento&#46; No hubo diferencias entre los grupos en los par&#225;metros fisiol&#243;gicos o eventos adversos &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;171&#41;&#59; un ni&#241;o &#40;6&#44;3&#37;&#41; del grupo MDZ-IM present&#243; hipotensi&#243;n&#44; y 5 del grupo DZP-IV &#40;31&#37;&#41; presentaron hiperactividad o v&#243;mitos&#46;</p></span> <span id="abst0075" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Conclusi&#243;n</span><p id="spar0080" class="elsevierStyleSimplePara elsevierViewall">Dada su eficacia&#44; facilidad y velocidad de administraci&#243;n&#44; MDZ-IM es una excelente opci&#243;n para el tratamiento de convulsiones infantiles&#44; posibilitando un tratamiento precoz y reduciendo la duraci&#243;n de la convulsi&#243;n&#46; No hubo diferencias en las complicaciones al aplicar MDZ-IM o DZP-IV&#46;</p></span>"
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                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Intramuscular midazolam&#40;<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>16&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Intravenous diazepam&#40;<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>16&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black"><span class="elsevierStyleItalic">p</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="table-entry  " align="left" valign="top"><span class="elsevierStyleItalic">Age &#40;months&#41;</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">46&#46;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>53&#46;1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">45&#46;0<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>49&#46;2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;451<a class="elsevierStyleCrossRef" href="#tblfn0005"><span class="elsevierStyleSup">&#42;</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Median &#40;range&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">13&#46;9 &#40;10&#46;7&#8211;70&#46;0&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">14&#46;3 &#40;4&#46;4&#8211;90&#46;8&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="" valign="top">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " colspan="4" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td" title="table-entry  " align="left" valign="top"><span class="elsevierStyleItalic">Weight &#40;kg&#41;</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">15&#46;9<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>10&#46;6&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">17&#46;7<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>13&#46;0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">1&#46;000<a class="elsevierStyleCrossRef" href="#tblfn0005"><span class="elsevierStyleSup">&#42;</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Median &#40;range&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">11&#46;5 &#40;8&#46;1&#8211;19&#46;2&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">13&#46;2 &#40;7&#46;2&#8211;26&#46;5&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="" valign="top">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " colspan="4" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td" title="table-entry  " align="left" valign="top"><span class="elsevierStyleItalic">Male sex&#44; n &#40;&#37;&#41;</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">12 &#40;75&#46;0&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">8 &#40;50&#46;0&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;273<a class="elsevierStyleCrossRef" href="#tblfn0010"><span class="elsevierStyleSup">&#8224;</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " align="left" valign="top"><span class="elsevierStyleItalic">Systolic blood pressure &#40;mmHg&#41;</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">99&#46;5<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>21&#46;6&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">102&#46;0<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>16&#46;4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;715<a class="elsevierStyleCrossRef" href="#tblfn0015"><span class="elsevierStyleSup">&#8225;</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " align="left" valign="top"><span class="elsevierStyleItalic">Diastolic blood pressure &#40;mmHg&#41;</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">61&#46;6<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>16&#46;1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">63&#46;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>12&#46;6&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;735<a class="elsevierStyleCrossRef" href="#tblfn0015"><span class="elsevierStyleSup">&#8225;</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " align="left" valign="top"><span class="elsevierStyleItalic">Body temperature &#40;&#176;C&#41;</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">37&#46;3<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">37&#46;0<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;670<a class="elsevierStyleCrossRef" href="#tblfn0015"><span class="elsevierStyleSup">&#8225;</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " align="left" valign="top"><span class="elsevierStyleItalic">Heart rate &#40;bpm&#41;</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">149&#46;2<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>29&#46;0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">137&#46;6<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>31&#46;6&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;289<a class="elsevierStyleCrossRef" href="#tblfn0015"><span class="elsevierStyleSup">&#8225;</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " align="left" valign="top"><span class="elsevierStyleItalic">Respiratory rate &#40;bpm&#41;</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">37&#46;0<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>16&#46;5&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">37&#46;1<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>9&#46;7&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;985<a class="elsevierStyleCrossRef" href="#tblfn0015"><span class="elsevierStyleSup">&#8225;</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " align="left" valign="top"><span class="elsevierStyleItalic">Oxygen saturation &#40;&#37;&#41;</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">90&#46;9<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>8&#46;7&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">90&#46;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>5&#46;3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;846<a class="elsevierStyleCrossRef" href="#tblfn0015"><span class="elsevierStyleSup">&#8225;</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " align="left" valign="top"><span class="elsevierStyleItalic">Blood glucose &#40;mg&#47;dL&#41;</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">116&#46;6<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>51&#46;6&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">116&#46;8<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>39&#46;1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;955<a class="elsevierStyleCrossRef" href="#tblfn0005"><span class="elsevierStyleSup">&#42;</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " align="left" valign="top"><span class="elsevierStyleItalic">Age</span><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">&#60;</span><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">5 years&#44; n &#40;&#37;&#41;</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">12 &#40;75&#46;0&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">10 &#40;62&#46;5&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;702<a class="elsevierStyleCrossRef" href="#tblfn0010"><span class="elsevierStyleSup">&#8224;</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " align="left" valign="top"><span class="elsevierStyleItalic">Febrile seizures&#44; n &#40;&#37;&#41;</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">7 &#40;43&#46;7&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">6 &#40;37&#46;5&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;718<a class="elsevierStyleCrossRef" href="#tblfn0010"><span class="elsevierStyleSup">&#8224;</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
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                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Per-protocol analysis &#40;treatment success only&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">3&#46;3<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;8&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " align="left" valign="top">Time from admission to cessation of seizures &#40;min&#41;&nbsp;\t\t\t\t\t\t\n
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Article information

ISSN: 21735727
Original language: English

DOI:10.1016/j.medine.2014.04.006

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2024 November	8	11	19
2024 October	52	53	105
2024 September	68	41	109
2024 August	78	48	126
2024 July	53	30	83
2024 June	67	46	113
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2024 March	40	24	64
2024 February	41	42	83
2024 January	36	32	68
2023 December	32	43	75
2023 November	33	34	67
2023 October	42	27	69
2023 September	41	40	81
2023 August	36	22	58
2023 July	74	33	107
2023 June	71	26	97
2023 May	114	27	141
2023 April	91	24	115
2023 March	117	35	152
2023 February	124	36	160
2023 January	145	32	177
2022 December	117	44	161
2022 November	143	37	180
2022 October	122	40	162
2022 September	99	40	139
2022 August	110	57	167
2022 July	81	41	122
2022 June	70	32	102
2022 May	66	43	109
2022 April	92	38	130
2022 March	95	41	136
2022 February	72	29	101
2022 January	89	32	121
2021 December	52	46	98
2021 November	54	36	90
2021 October	83	72	155
2021 September	51	50	101
2021 August	50	47	97
2021 July	43	31	74
2021 June	53	35	88
2021 May	84	43	127
2021 April	248	108	356
2021 March	191	43	234
2021 February	119	19	138
2021 January	95	27	122
2020 December	85	34	119
2020 November	82	29	111
2020 October	67	25	92
2020 September	54	30	84
2020 August	50	16	66
2020 July	40	15	55
2020 June	60	19	79
2020 May	43	17	60
2020 April	39	14	53
2020 March	26	11	37
2020 February	88	18	106
2020 January	40	28	68
2019 December	50	12	62
2019 November	40	24	64
2019 October	59	21	80
2019 September	45	22	67
2019 August	60	26	86
2019 July	39	27	66
2019 June	20	13	33
2019 May	39	30	69
2019 April	20	16	36
2019 March	12	29	41
2019 February	23	29	52
2019 January	33	31	64
2018 December	43	53	96
2018 November	50	46	96
2018 October	33	22	55
2018 September	13	6	19
2018 August	13	6	19
2018 July	16	5	21
2018 June	12	14	26
2018 May	10	3	13
2018 April	12	7	19
2018 March	11	5	16
2018 February	14	9	23
2018 January	21	9	30
2017 December	25	9	34
2017 November	12	5	17
2017 October	17	9	26
2017 September	19	8	27
2017 August	11	6	17
2017 July	20	6	26
2017 June	19	9	28
2017 May	23	8	31
2017 April	22	9	31
2017 March	24	4	28
2017 February	22	4	26
2017 January	5	4	9
2016 December	17	5	22
2016 November	32	6	38
2016 October	34	15	49
2016 September	26	4	30
2016 August	20	4	24
2016 July	22	9	31

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