Intra-Nasal vs. Intra-Venous Lorazepam for Control of Acute Seizures in Children: Prospective Open Labeled Randomized Equivalence Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Cessation of all clinical seizure activity within 10 min of drug administration
研究概览
简要总结
Status epilepticus (SE) is a common pediatric emergency which is potentially life-threatening and requires rapid termination. Early and effective treatment is essential to prevent the morbidity and mortality associated with prolonged convulsive SE. Lorazepam is the standard of care for control of SE when administered by intra-venous (IV) route. The investigators intend to compare efficacy and adverse effect profile of intra-nasal vs. intravenous routes of administration of lorazepam. In resource poor settings, sometimes trained personnel or appropriate equipment for intra-venous cannulation is not available. Alternate routes of administration, if shown equivalent to conventional IV route, will be very useful in such settings or for out of hospital management of seizures in children.
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
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children presenting convulsing to the pediatric emergency or developing seizure while in casualty
- •Age 6-14 years
排除标准
- •Known hypersensitivity to any benzodiazepine
- •Child has received any parenteral anti-convulsant within 1 hr prior to enrollment
- •Presence of severe cardio-respiratory compromise or cardiac arrhythmias
- •Presence of upper respiratory tract infection
- •Presence of basal skull fracture causing cerebro-spinal fluid (CSF) rhinorrhea
研究组 & 干预措施
1
Intra-nasal lorazepam 0.1 mg/kg (max 4 mg)
干预措施: Lorazepam (Drug)
2
Intra-venous lorazepam 0.1 mg/kg (max 4 mg)
干预措施: Lorazepam (Drug)
结局指标
主要结局
Cessation of all clinical seizure activity within 10 min of drug administration
时间窗: 10 min
次要结局
- Persistent cessation of seizure activity for 1 hr(1 hr)
- Time to achieve intra-venous access after arrival in casualty(minutes)
- Patients requiring rescue medication within 1 hr(1 hr)
- Time from drug administration to termination of seizure(s)(minutes)
- Development of hypotension (fall of >/= 20 mmHg systolic and/ or >/= 10 mmHg diastolic pressure) within 1 hr of drug administration(1 hr)
- Development of significant respiratory depression requiring assisted ventilation(1 hr)