Intravenous Levetiracetam versus Intravenous Phenytoin for Second line treatment of Pediatrics Convulsive Status Epilepticus - Open label Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Absence of clinically apparent seizures after 5 minutes of completion of trial drug infusion without additional anticonvulsants medication.
研究概览
简要总结
This study is a open label randomized controlled trial to compare the efficacy and safety of intravenous Levetiracetam and phenytoin as second line anticonvulsants drug in aborting seizure in Pediatrics status epilepticus. Randomisation will be done by stratified block randomisation and after randomisation group one will receive Levetiracetam 40mg/kg over 5 minutes and group two will receive phenytoin 20mg/kg over 20 minutes .clinical cessation of seizures is assessed after 5 minutes of completion of trial drug infusion. The maintenance dose of Levetiracetam will be started after 12 hours of loading dose and phenytoin after 24 hours in respective group . If seizure still persists after first dose of Levetiracetam and phenytoin ,then cross over will be done . The maintenance dose of Levetiracetam will be started after 12 hours of loading dose and phenytoin after 24 hours in both the group. If seizure doesn’t abort then clinical decision shall be given to treating clinicians and outcome of the patient will be followed up to exit from the study and analysed as per intention to treat .
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 3.00 Month(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Presenting with generalized tonic clinic ,generalized clonic,generalized tonic,generalised myoclonic ,focal tonic or focal clonic seizures
- •Children who had received 2 doses of midazolam
- •Children who had received 2 doses of midazolam for generalized convulsive seizures lasting more than 5 minutes and continued to have persistent or recurrent convulsions in the emergency department at least 5 minutes after the last dose of benzodiazepines
- •Patient on maintenance dose of phenytoin and Levetiracetam with bad compliance.
排除标准
- •1.Age<3 months and >15 years of age .
- •Children presenting with absence seizures or infantile spasms .
- •Convulsive status Epilepticus due to hypocalcemia,hypoglycaemia,hypercalcemia .
- •Patient had received second line Anticonvulsant during the episode of convulsive status epilepticus .
- •Patients with arrhythmia .
- •Patients allergic to Levetiracetam and phenytoin .
- •Patients already on maintenance dose of phenytoin and Levetiracetam with good compliance .
- •Seizure controlled with 2 doses of midazolam .
- •Parents / care providers not giving consent .
结局指标
主要结局
Absence of clinically apparent seizures after 5 minutes of completion of trial drug infusion without additional anticonvulsants medication.
时间窗: 2 years
次要结局
- Patients requiring further anticonvulsants to manage convulsive status epilepticus,recurrence of seizures, change in cardio respiratory parameter ,need for admission to PICU and any drug related serious adverse reactions .(2 years)