Ketamine-midazolam vs fentanyl-midazolam combination as induction agents for tracheal intubation in critically ill children: a pilot, feasibility, open label, randomized control trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of adverse hemodynamic events defined as bradycardia defined as heart rate less than 60 minutes or hypotension requiring fluid bolus/inotrope or fall in systolic blood pressure by 30% of pre intubation value or increase in inotrope/vasopressor requirement by 30% from pre intubation requirement or cardiac arrest with or without ROSC from the beginning of induction up to 30 minutes after intubation
研究概览
简要总结
We will be conducting a feasibility ,pilot, open label RCT to see if use of induction regimens containing ketamine reduce the incidence of tracheal intubation related adverse events in critically ill children. We will enrol eligible children aged 2months to 18 years admitted in pediatric wards, HDU and PICU of the department during the study period. The children will be randomised to 2 groups. One group will receive midazolam- fentanyl combination while the other will receive ketamine-midazolam combination prior to tracheal intubation.Both the groups will receive premedication of glycopyrrolate. Heart rate, ECG and blood pressure of the patients will be monitored at baseline and at 1,3,5,7,15,20 and 30 minutes after intubation. The child will be managed for the underlying illness as per the unit protocols. Primary and secondary outcome measures are measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 2.00 Month(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Critically ill children, age 2 month (corrected age).
- •18 years admitted in wards, HDU and PICU.
- •With one or more organ dysfunction AND.
- •Requiring tracheal intubation.
- •Patients who have already been enrolled before but are meeting inclusion criteria at a different time point and not on any sedative- analgesics at the time of current enrolment.
排除标准
- •Known hypersensitivity to Ketamine -Hypertensive urgency and emergency -Craniofacial malformation -Mucopolysaccaridoses/ mucolipidoses -Pierre robin sequence -Down’s syndrome -History of face/neck trauma/burns/radiation -Neck masses -Patients presenting with cardiopulmonary arrest or being intubated for cardiopulmonary arrest.
结局指标
主要结局
Incidence of adverse hemodynamic events defined as bradycardia defined as heart rate less than 60 minutes or hypotension requiring fluid bolus/inotrope or fall in systolic blood pressure by 30% of pre intubation value or increase in inotrope/vasopressor requirement by 30% from pre intubation requirement or cardiac arrest with or without ROSC from the beginning of induction up to 30 minutes after intubation
时间窗: Before intubation and at o,1,3,5,7,10,15,20,25 and 30 minutes after endotracheal intubation
次要结局
- Incidence of other Tracheal Intubation associated Adverse Events (TIAEs) defined as trauma, emesis with or without aspiration, endobronchial/esophageal intubation, dysrhythmia, laryngospasm, pneumothorax(Trauma and laryngospasm will be assessed at the time of intubation.)
- Proportion of the encounters requiring neuromuscular blocker use(At the time of intubation)
- Proportion of encounters requiring repeat doses of sedatives to achieve adequate sedation((State 1/2 as assessed using Pediatric Sedation State Scale))