Levetiracetam and Midazolam vs Midazolam Alone for First-Line Treatment of Children With Generalized Convulsive Status Epilepticus (Lev-Mid Study): A Randomized Controlled Trial

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dc.contributor.authorElshater, Ahmed Aen_US
dc.contributor.authorSadek, Abdelrahim Aen_US
dc.contributor.authorAbdelkreem, Elsayeden_US
dc.date.accessioned2023-08-25T06:40:00Z
dc.date.available2023-08-25T06:40:00Z
dc.date.issued2023-08
dc.description.abstractBackground:Benzodiazepines are the first-line anti-seizure medication (ASM) for generalized convulsive status epilepticus (GCSE), but they fail to end seizures in a third of cases. Combining benzodiazepines with another ASM that acts by a different pathway could be a potential strategy for rapid control of GCSE. Objectives: To evaluate the efficacy of adding levetiracetam to midazolam in the initial treatment of pediatric GCSE. Design: Double-blind randomized controlled trial. Setting: Pediatric emergency room at Sohag University Hospital between June, 2021 and August, 2022. Participants: Children aged between 1 month and 16 years with GCSE lasting more than 5 min. Interventions: Intravenous levetiracetam (60 mg/kg over 5 min) and midazolam (Lev-Mid group) or placebo and midazolam (PlaMid group) as first-line anticonvulsive therapy. Outcome measures: Primary: cessation of clinical seizures at 20- min study time point. Secondary: cessation of clinical seizures at 40-min study time point, need for a second midazolam dose, seizure control at 24-hr, need for intubation, and adverse effects. Results: Cessation of clinical seizures at 20-min occurred in 55 children (76%) in Lev-Mid group compared with 50 (69%) in the PlaMid group [RR (95% CI) 1.1 (0.9-1.34); P=0.35]. No significant difference was found between the two groups regarding the need for a second midazolam dose [44.4% vs 55.6%; RR (95% CI) 0.8 (0.58- 1.11); P=0.18] as well as cessation of clinical seizures at 40-min [96% vs 92%; RR (95% CI)1.05 (0.96-1.14); P=0.49] and seizure control at 24-hr [85% vs 76%; RR (95% CI) 1.12 (0.94-1.3); P=0.21]. Intubation was required for three patients in the Lev-Mid group and six patients in the Pla-Mid group [RR (95%CI) 0.5 (0.13- 1.92); P=0.49]. No other adverse effects or mortality were observed during the 24-hour study timeframe. Conclusion: Combined levetiracetam and midazolam for initial management of pediatric GCSE presents no significant advantage over midazolam alone in cessation of clinical seizures at 20-min.en_US
dc.identifier.affiliationsDepartment of Pediatrics, Faculty of Medicine, Sohag University, Sohag, Egypten_US
dc.identifier.citationElshater Ahmed A, Sadek Abdelrahim A, Abdelkreem Elsayed. Levetiracetam and Midazolam vs Midazolam Alone for First-Line Treatment of Children With Generalized Convulsive Status Epilepticus (Lev-Mid Study): A Randomized Controlled Trial. Indian Pediatrics. 2023 Aug; 60(8): 630-636en_US
dc.identifier.issn0079-6061
dc.identifier.issn0974-7559
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/225446
dc.languageenen_US
dc.publisherIndian Academy of Pediatricsen_US
dc.relation.issuenumber8en_US
dc.relation.volume60en_US
dc.source.urihttps://indianpediatrics.net/aug2023/630.pdfen_US
dc.subjectAnti-seizure medicationen_US
dc.subjectBenzodiazepinesen_US
dc.subjectManagementen_US
dc.subjectTonic clonic seizure.en_US
dc.titleLevetiracetam and Midazolam vs Midazolam Alone for First-Line Treatment of Children With Generalized Convulsive Status Epilepticus (Lev-Mid Study): A Randomized Controlled Trialen_US
dc.typeJournal Articleen_US
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