Comparison Between Efficacy of Levetiracetam Versus Valproic Acid in Pediatric Patients With Status Epilepticus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Sustained control of seizure activity
研究概览
简要总结
Since there is a significant degree of variability in the results of previous studies and there exists a thirst for local data regarding this topic, the current study was planned, with the objective of comparing the efficacy of levetiracetam versus valproic acid in pediatric patients with status epilepticus.
详细描述
Early and sustained control of seizures is paramount in status epilepticus to save the life of the patient, and this warrants the use of the best drug based on evidence. Identifying a better drug in status epilepticus would add to the local data and help clinicians in making evidence-based decisions to opt for an appropriate treatment in case of failed response to benzodiazepines.
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
- 2 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any gender
- •Aged 2-14 years
- •Presenting with status epilepticus
排除标准
- •Patients with focal seizures
- •Patients already using valproic acid or levetiracetam
- •Patients with a history of hypersensitivity to either drug
研究组 & 干预措施
Levetiracetam group
In this group, patients were treated with intravenous levetiracetam (LEV) 20 mg/kg over 15 minutes, followed by 60 mg/kg/day in two divided doses over 24 hours.
干预措施: Levetiracetam (Drug)
Valproic acid group
Patients received intravenous valproic acid at 15 mg/kg over 15 minutes, followed by 20 mg/kg/day in two divided doses over 24 hours.
干预措施: Valproic acid (Drug)
结局指标
主要结局
Sustained control of seizure activity
时间窗: 24 hours
Sustained control was labeled when there was no seizure activity on EEG and regain of consciousness for ≥ 24 hours
次要结局
- Immediate cessation of seizure activity(30 minutes)