Efficacy of Ketamine in Refractory Convulsive Status Epilepticus in Children: a Multicenter, Randomized, Controlled, Open-label, No-profit, With Sequential Design Study.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Number of participants with resolution of refractory convulsive status epilepticus
研究概览
简要总结
To evaluate the efficacy of intravenous administration of ketamine in the treatment of refractory convulsive status epilepticus in children compared to administration of midazolam at high doses, thiopental and / or propofol.
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis and clinical EEGrafica of refractory convulsive status epilepticus
- •Refractoriness of the drug I and II line
- •Written informed consent from parents or legal guardian.
- •Administration of rating scales in the risk of mortality (PIM III) and severity of SE (stess, status epilepticusseverity score) to be performed prior to randomization.
排除标准
- •contraindications to the use of the medication/s in the study.
- •pregnant or suspected pregnant.
研究组 & 干预措施
ketamine up to 100 mcg/kg/min
Two intravenous boluses of 2-3 mg/kg each of ketamine will be administered 5 minutes apart and immediately followed by a continuous infusion of 5-10 mcg/kg/min. Based on both clinical or electrographic responses, dosage will be increased every 10 minutes or longer, using 2 to 10 mcg/kg/ min increments, up to 60 mcg/kg/min. Maximum duration of infusion will be of 7 days.
干预措施: Ketamine (Drug)
midazolam & thiopental & propofol
Midazolam intravenous will be increased every 5 minutes, using 2 mcg/kg/min increments, up to 12 mcg/kg/min and Thiopental intravenous will be increased every 30 minutes or longer, using 1 mg/kg/h increments, up to 6 mg/kg/h and Propofol intravenous will be increased every 5 minutes or longer, using 1 mg/kg/h increments, up to 5 mg/kg/h.
Maximum duration of infusion for each drug will be 48 hours.
干预措施: Ketamine (Drug)
结局指标
主要结局
Number of participants with resolution of refractory convulsive status epilepticus
时间窗: participant wil be followed for 24 hours after discontinuation of study drug
次要结局
未报告次要终点
研究者
Anna Rosati
MD, PhD
Meyer Children's Hospital IRCCS