Comparing the efficacy of intravenous Levetiracetam versus intravenous Valproate in the management of refractory status epilepticus in children : a randomised trial
试验速览
- 阶段
- 4 期
- 状态
- Other
- 发起方
- pgimer
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- •Proportion of children in either group who have Cessation of all clinical seizure within 15 min of drug administration and no recurrence for the next 6 hours
研究概览
简要总结
This study is a randomized, open label, parallel group,comparing the safety and efficacy of valproate and levetiracetam in patients of age group 2 to 12 years with status epilepticus not responded to phenytoin 30 mg/kg and benzodiazepines approaching to pediatric emergency , pgimer The primary outcome measures will be Proportion of children in either group who have Cessation of all clinical seizure within 15 min of drug administration and no recurrence for the next 6 hours and secondary outcome will be time taken to control seizure (minutes) from the initiation of infusion, Proportion of children in either group who required additional drugs to abort ongoing clinical seizures, Rates of adverse events (hypotension, bradycardia, respiratory depression, ventilation, PICU stay, in hospital mortality) in the two groups were measured
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 2.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Children aged 2 to 12 years old of either sex with ongoing clinical seizures(clonic, tonic, tonic clonic, myoclonic, focal or generalized) •Clinical seizures despite use of one or more doses of benzodiazepines (IV, IN, Buccal) and IV Phenytoin of 30 mg/kg or includes those who respond to initial doses (30 mg/kg ) of phenytoin but have recurrence within 6 hours of drug administration.
排除标准
- •â€¢Non-convulsive status epilepticus .
- •Known or suspected cases of neurometabolic or mitochondrial disorders •Acute or chronic liver or kidney disease •Head injury or neurosurgery in the past one month.
- •â€¢Active or recent hemorrhage from any site •Documented platelet count <50,000, or INR>2 •Known or suspected allergy or intolerance to either valproate or levetiracetam •Patients of epilepsy already on LEV(>20mg/kg/day) or VPA(>20mg/kg/day).
结局指标
主要结局
•Proportion of children in either group who have Cessation of all clinical seizure within 15 min of drug administration and no recurrence for the next 6 hours
时间窗: 15 min
次要结局
- •Time taken to control seizure (minutes) from the initiation of infusion(•Proportion of children in either group who required additional drugs to abort ongoing clinical seizures)