Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Cessation of seizure activity five minutes after treatment with study medication.
研究概览
简要总结
The goal of this study is to prove that intramuscular midazolam is more effective than buccal midazolam in cessation of seizure activity with comparable side effects.
详细描述
Both buccal and intramuscular midazolam have been used to control seizures with variable succuss rates and side effects.
In this study the investigators are going to assign patient randomly to receive either buccal or intramuscular midazolam. Then will compare both efficacy and side effect in both groups.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 6 month to 14 years who will be presented to the pediatric emergency or attended by emergency medical service who have active seizure and had no intravenous access would be eligible for the study.
排除标准
- •Cardiac arrest
- •Head trauma
- •Congenital heart disease
- •Inborn errors of metabolism
- •Electrolyte imbalance (hypocalcaemia, hyponatremia and hypoglycemia)
- •Hemodynamic instability
- •Allergy to benzodiazepines
- •Focal seizures with preserved level of consciousness
研究组 & 干预措施
Buccal midazolam
Study subject will receive buccal midazolam and intramuscular placebo. The dose of buccal midazolam is 0.3 mg/kg
干预措施: Buccal midazolam (Drug)
intramuscular midazolam
Study subject will receive intramuscular midazolam and buccal placebo. The dose of intramuscular midazolam is 0.25 mg/kg.
干预措施: Intramuscular midazolam (Drug)
结局指标
主要结局
Cessation of seizure activity five minutes after treatment with study medication.
时间窗: five minutes
Cessation of abnormal motor activity with regaining of consciousness.
次要结局
- Major side effects.(2 hours after cessation of seizures.)
- Duration of seizure.(5 minutes)
- Recurrence of seizure activity within one hour after treatment with study medication.(one hour)
研究者
DR. KHALID AL-ANSARI
Senior consultanat
Hamad Medical Corporation