Safety and Efficacy of Intravenous Brivaracetam Versus Levetiracetam in the Management of Status Epilepticus in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Cessation of seizures
研究概览
简要总结
Brivaracetam is increasingly being studied in adult status epilepticus populations, evidence in pediatric patients remains sparse, with only limited case series and observational studies reporting favorable outcomes. This study aims at direct comparison between intravenous brivaracetam and levetiracetam in the acute management of pediatric status epilepticus.
详细描述
Given the urgent need for safe and effective alternatives in pediatric status epilepticus and the limited head-to-head data comparing intravenous brivaracetam with levetiracetam, especially in children, this study has been designed to evaluate their relative safety and efficacy. The research seeks to generate evidence that may help guide clinical decision-making and optimize outcomes in this vulnerable population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Either gender
- •Aged one month to 16 years
- •Presenting with status epilepticus
排除标准
- •Previously received intravenous antiseizure medication for the current episode prior to presentation
- •Known hypersensitivity to study drugs
- •Hemodynamically unstable, requiring inotropic support before administration
研究组 & 干预措施
Brivaracetam group
Patients received brivaracetam as a loading dose of 2 mg/kg (maximum 100 mg) diluted in 100 ml of normal saline infused over 10 minutes.
干预措施: Intravenous brivaracetam (Drug)
Levetiracetam group
Patients received levetiracetam as a loading dose of 40 mg/kg (maximum 3000 mg) diluted in 100 ml of normal saline infused over 10 minutes.
干预措施: Intravenous levetiracetam (Drug)
结局指标
主要结局
Cessation of seizures
时间窗: 30 minutes
Cessation of seizures was labeled "yes" if cessation of clinical seizures occurred within 20-30 minutes of infusion without the need for additional antiseizure medication.
次要结局
- Adverse Events(40 minutes)
研究者
Muhammad Aamir Latif
Research Consultant
RESnTEC, Institute of Research