Sedation Efficacy of Dexmedetomidine Versus Midazolam in Critically Ill Ventilated Children
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Target Sedation Range
研究概览
简要总结
There is a significant lack of adequately powered randomized clinical trial (RCT) data to determine the comparative safety and effectiveness of sedative treatments in pediatric patients. In many centres the standard of care for sedation in pediatric critical care unit (PCCU) patients includes the use of benzodiazepines despite the known negative effects of increased patient agitation and delirium, which can contribute to longer PCCU and hospital length of stay (LOS). The use of an alternative sedative, dexmedetomidine may reduce negative effects in this population. As such, the investigators plan to conduct a well designed comparative RCT to determine the most effective and safest sedative in this vulnerable population utilizing clinical assessments of sedation levels and delirium instance, electroencephalography (EEG) analysis and patient important outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age is 1 month to 18 years inclusive
- •The patient is intubated and is expected to remain intubated for at least the next 48 hours
- •The patient has not been receiving mechanical ventilation for more than 72 hours
- •The patient must already be receiving an opioid infusion per PCCU Guidelines for Sedation & Analgesia for Procedures Outside O.R. and need additional sedation.
排除标准
- •Admission is a consequence of suspected or proven drug overdose
- •Patient is receiving dialysis
- •Known pregnancy or lactation
- •Neuromuscular blockade other than for intubation
- •General anesthesia in the 24 hours prior to study initiation
- •An acquired Central Nervous System (CNS) condition (i.e. encephalitis, traumatic brain injury) resulting in ongoing dysfunction or an acquired condition resulting in ongoing dysfunction
- •Acute hepatitis or severe liver disease
- •Known history of sensitivity to midazolam and/or dexmedetomidine or their constituents
- •Systolic blood pressure (SBP) below 5th percentile for two consecutive measurements
- •Heart rate (HR) below 5th percentile for two consecutive measurements
- •Death is deemed to be imminent or inevitable during the admission and either the intensivist or substitute decision maker is not committed to full active resuscitation
- •Previous enrollment into the study
研究组 & 干预措施
Dexmedetomidine
干预措施: Precedex (Drug)
Midazolam
干预措施: Midazolam (Drug)
结局指标
主要结局
Target Sedation Range
时间窗: Up to 14 days post-randomization
The percentage of time spent within target sedation range, defined as COMFORT Behaviour Scale score of 11-22, which will be assessed at minimum every 4 hours.
次要结局
- Delirium(Up to 14 days post-randomization)
- Pharmacokinetics - Area under the plasma concentration-time curve (AUC)(Up to 14 days post-randomization)
- Use of open label boluses for sedation - number(Up to 14 days post-randomization)
- Use of open label boluses for sedation - total dose(Up to 14 days post-randomization)
- Duration of mechanical ventilation(Up to 28 days post-randomization)
- PCCU Length of Stay(Up to 90 days post-randomization)
- Hospital Length of Stay(Up to 90 days post-randomization)
- Adverse event (AE) occurrence(Randomization to 90 days post-randomization)
- Quantification of sleep stages and sleep quality assessment(Up to 14 days post-randomization)
- Pharmacokinetics - Maximum plasma concentration (Cmax)(Up to 14 days post-randomization)
研究者
Douglas Fraser
Paediatric Intensivist
Lawson Health Research Institute