Prospective, Randomized, Open Label Controlled Trial To Evaluate The Safety And Efficacy Of Dexmedetomidine Use Beyond 24 Hours Compared With Midazolam In Children Admitted To Pediatric Intensive Care Unit (PICU) at KASCH-MNGHA.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 430
- 试验地点
- 1
- 主要终点
- Mean time taken from end of sedation to extubation with no or minimal withdrawal symptoms
研究概览
简要总结
Study will be conducted in Pediatric Intensive Care Unit (PICU) in King Abdullah Specialist Children Hospital (KASCH), National Guard Health Affairs, Riyadh, Saudi Arabia. Total of 430 patients will participate to assess the safety and efficacy of prolonged Dexmedetomidine use beyond 24 hours in pediatric Intensive Care Unite.
详细描述
Prospective, randomized, open label, controlled study, will be conducted in Pediatric Intensive Care Unit (PICU) in King Abdullah Specialist Children Hospital (KASCH), National Guard Health Affairs, Riyadh, Saudi Arabia. 340 patients will be randomly randomized to Midazolam (M) or Dexmedetomidine (D), to assess the safety and efficacy of prolonged Dexmedetomidine use beyond 24 hours.
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
- 1 Year 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1-14 years both male and female who require mechanical ventilation
- •Informed consent from signed by patient's legal representatives, and for patients aged 12- 14 who has an age-appropriate understanding additional assent form signed by patient is required.
- •Intubated within 6 hours and anticipated to require mechanical ventilation for more than 48 hours
排除标准
- •Septic shock and/or multi-organ failure.
- •Hemodynamically instability and requires inotropes.
- •Severe intracranial or spinal trauma with high intracranial pressure
- •Liver failure
- •Acute or chronic renal failure.
- •Glasgow Coma Scale (GCS) ≤8
- •Known to have allergy to the study drugs
- •Airway surgery
研究组 & 干预措施
Dexmedetomidine (D)
Infusion start at 0.5 mcg/kg/hour. Titrate to effect (up to1.5 mcg/kg/hour)
干预措施: Dexmedetomidine (Drug)
Midazolam (M)
1 mcg/kg/minute. Up to a maximum of 5 mcg/kg/minute.
干预措施: Midazolam (Drug)
结局指标
主要结局
Mean time taken from end of sedation to extubation with no or minimal withdrawal symptoms
时间窗: from end of sedation to extubation assessed up to 24 hrs
次要结局
- To compare length of PICU stay in both groups(from Intubation to discharge assessed up to 1 month)