Comparison between intranasal midazolam and intravenous midazolam in children with seizures (randomised controlled study)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Intranasal midazolam group –repeat one more dose of Intranasal midazolam-if at all
研究概览
简要总结
This prospective randomized controlled trial will be conducted in the casualty,picu, SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL after the approval of research committee and institutional ethics committee. Children in the age group of 6 months to 13 years presenting with acute seizures based on risk of recurrence, child was admitted in emergency department or pediatrics department ICU in SMVMCH fulfilling inclusion criteria will be considered for the study. Randomization technique will be used to select the intervention Group A(Intranasal midazolam ) and Group B (intravenous midazolam) to be given to the study participants. An online resource (www.sealedenvelope.com) will be used to create this block randomized list. The random list order of interventions will be printed in cards and kept in sealed envelopes in the order as in the list. Each envelope will be opened just before the procedure and the intervention which is written on the card will be administered. The list generated is attached as an annexure. The block randomization will be done in two study groups. Group A (Intranasal midazolam ) and Group B (Intravenous midazolam).The route of drugs given by two methods will re assessed at every 3-5 minutes . If Children not meeting the inclusion criteria will be excluded from the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 6.00 Month(s) 至 5.00 Year(s)(—)
- 性别
- All
入选标准
- •Children with acute seizure, febrile seizure, unprovoked seizure, provoked seizure,Children who are a known case of seizure disorder.
排除标准
- •Children with prolonged seizure(status epilepticus), Children‟s with renal diseases, Children with hypoglycemic seizures, hypocalcemic seizure, URI.
结局指标
主要结局
Intranasal midazolam group –repeat one more dose of Intranasal midazolam-if at all
时间窗: 2 MINS
seizure does not abort the Principal Investigator should shift to Intravenous midazolam
时间窗: 2 MINS
routes.
时间窗: 2 MINS
次要结局
- Intravenous midazolam - if seizure does not abort in first dose of Intravenous midazolam –(repeat one more dose of Intravenous midazolam . If at all seizure does not abort in Intranasal)
研究者
Dr TN MOHAMMED NADHEEM
Sri manakula vinayagar medical college and hospita
