Intramuscular Versus Buccal Midazolam for Pediatric Seizures: A Randomized Double-Blinded Trial - 23/07/20
, Magda Barkat, MD, FAAP c, AbdelNasir H. Mohamed, MD c, Shahaza Alali Al Jawala, MD c, Shadi Ahmad Othman, MD cAbstract |
Background |
We compared the efficacy and safety of intramuscular with buccal midazolam as first-line treatment for active seizures in children brought to the emergency department.
Methods |
In a double-blind, double-dummy randomized trial, patients with an active seizure lasting more than five minutes received blinded treatments on arrival. We employed deferred consent. The proportion of patients with cessation of seizure within five minutes of drug administration was the primary efficacy outcome; proportions needing additional medication to control seizure, duration of seizure activity, and side effects were secondary outcomes.
Results |
We enrolled 150 children presenting with active seizure, age range 4.5 to 167.5 months. Cessation of seizure occurred in 61% of the intramuscular and 46% of the buccal treatment groups, (P = 0.07, difference 15.5%, 95% confidence interval for the difference −1.0 to 32.0%). Proportions requiring additional anti-seizure treatment were 39% in the intramuscular and 51% in the buccal groups. Mean duration of seizure activity after administration of study medication was 15.9 minutes (S.D. 28.7) in the intramuscular and 17.8 minutes (S.D. 27.5) in the buccal group. One patient in the intramuscular group developed respiratory depression and hypotension; there were no side effects attributed to investigational treatment in the buccal group.
Conclusions |
Efficacy and safety of intramuscular midazolam as first-line treatment for pediatric seizures compare favorably to that of buccal midazolam.
Le texte complet de cet article est disponible en PDF.Keywords : Seizure, Midazolam, Buccal, Intramuscular, Length of stay, Cessation of seizure, Status epilepticus
Plan
| Funding source: This study was hospital-sponsored by Sidra Medicine with a grant of US $50,000. |
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| Financial disclosure, conflict of interest, role of sponsor: The authors have no financial relationships relevant to this article to disclose. The authors have no conflicts of interest relevant to this article to disclose. The study was funded by Sidra Medicine, which had no role in: (1) study design; (2) the collection, analysis, and interpretation of data; (3) the writing of the report; and (4) the decision to submit the paper for publication. The authors have no conflict of interest to disclose. Dr. Khalid Alansari wrote the first draft. No form of payment was given to anyone to produce the manuscript. |
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| Data statement: Deidentified individual participant data (including data dictionaries, related documents) will not be made available. |
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| Clinical trial registration: www.clinicaltrials.gov (identifier NCT02897856). |
Vol 109
P. 28-34 - août 2020 Retour au numéro
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