EUCTR2013-004396-12-IT进行中（未招募）1 期
Efficacy of ketamine in refractory convulsive status epilepticus in children: a multicenter, randomized, controlled, open-label, no-profit, with sequential design study. - KETASER01
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 57
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Patients 1 month to 18 years old.
- •2) Diagnosis and clinical EEGrafica of refractory convulsive status epilepticus
- •3) Refractoriness of the drug I and II line
- •4) Written informed consent from parents or legal guardian.
- •5) 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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 57
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) contraindications to the use of the medication/s in the study.
- •2) pregnant or suspected pregnant.
研究者
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