Efficacy of Dexmedetomidine compared to Midazolam for sedation in mechanically ventilated patients in Pediatric Intensive Care Unit- A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Efficacy of sedation
研究概览
简要总结
We wish to test the efficacy of dexmedetomidine vs midazolam infusions for sedation of mechanically ventilated children in PICU, JIPMER. All children who meet inclusion criteria, after consent, will be started on either dexmedetomidine or midazolam infusion for sedation, and infusions will be prepared in such a way that dosing range will be 0.3-1.5 mcg/kg/hour for dexmedetomidine, and 1-5 mcg/kg/min for midazolam. Infusions will be prepared in such a way that this will correspond to 1-5 ml/hour rate for both drugs. Investigator, participants and outcome assessors will be blinded. Efficacy of sedation will be assessed using sedation scores every 6 hourly, and assessing the proportion of measurements, out of total measurements, when child was in adequate sedation. Means of the proportion between the two groups will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.00 Month(s) 至 16.00 Year(s)(—)
- 性别
- All
入选标准
- •Mechanically ventilated children in PICU.
排除标准
- •Children with raised intracranial pressure, HIE sequelae, refractory shock, bradycardia.
结局指标
主要结局
Efficacy of sedation
时间窗: 5 days
次要结局
- Delirium, Bolus doses of sedoanalgesia, iatrogenic withdrawal syndrome, adverse effects(5 days)
研究者
Narayanan P
Professor, Pediatrics
