New Approaches to Pediatric Sedation: Adjunctive Clonidine in the Sedation of Mechanically Ventilated Children (NAPS Pilot Trial)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Protocol adherence.
研究概览
简要总结
Almost all critically ill children who are mechanically ventilated require sedation and analgesia. Providing effective sedation for children in the PICU requires careful balancing of the need for sedation with the adverse effects associated with sedative medications. Clonidine is often used as an adjunctive sedative and analgesic in children but a well designed and adequately powered randomized trial is required to test the effect of clonidine-based sedation. Because there are no large randomized trials of sedation related interventions among critically ill children there are many unknown factors. This pilot trial, focussing on feasibility outcomes will assess the feasibility of, and inform the design of, a larger randomized controlled trial which will focus on clinically important outcomes.
详细描述
Almost all critically ill children who are mechanically ventilated require sedation and analgesia. Providing effective sedation for children in the PICU requires careful balancing of the need for sedation with the adverse effects associated with sedative medications. Inadequate sedation may result in undue pain and suffering for children, ventilator dysynchrony and may risk removal of life sustaining devices. Excess sedation limits patients' interaction with their parents and care-givers and may result in delayed weaning from mechanical ventilation, prolonged PICU stay and the attendant risks of increased morbidity. Critically ill children may also experience withdrawal when these medications are stopped. Randomized trails in adults have shown that sedation related interventions can improve patients outcomes, but such trials have not been performed in children.
Clonidine is often used as an adjunctive sedative and analgesic in children but a well designed and adequately powered randomized trial is required to test the effect of clonidine-based sedation. Because there are no large randomized trials of sedation related interventions among critically ill children there are many unknown factors.
This pilot trial, focussing on feasibility outcomes will assess the feasibility of, and inform the design of, a larger randomized controlled trial which will focus on clinically 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
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 1 month to 18 years
- •mechanically ventilated
- •the attending physician expects to require mechanical ventilation for at least 2 more days
- •requires sedation in the form of: morphine by continuous infusion or greater than 4 intermittent doses in the previous 24 hours or fentanyl as a continuous infusion AND midazolam or lorazepam by continuous infusion or more than 3 intermittent doses of lorazepam or 6 doses of midazolam in the previous 12 hours
- •has enteral access (gastric or jejunal feeding tube)
排除标准
- •hemodynamically unstable
- •meet the American College of Critical Care Medicine hemodynamic definition of shock
- •hypotensive or tachycardic
- •bradycardia, hemodynamically significant cardiac disease or chronic use of anti-hypertensive or diuretic medications
- •a traumatic brain injury on admission
- •chronically (defined as routine administration prior to hospital admission or for greater than 7 days in hospital prior to PICU admission) use benzodiazepines or opioids
- •have received greater than two doses of clonidine within the previous 2 days or dexmedetomidine in the past 2 days
- •were previously enrolled in this study
- •are currently enrolled in a related study
- •are known to be pregnant or breastfeeding
- •are known to be allergic to clonidine or any other ingredient in the tablets or suspension
- •are being considered for organ procurement
- •were chronically (>30 days) ventilated prior to PICU admission
- •are currently receiving, or are expected to initiate the ketogenic diet
- •are receiving cyclosporine or methylphenidate
研究组 & 干预措施
clonidine
干预措施: clonidine (Drug)
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Protocol adherence.
时间窗: 90 days
Enrollment rate.
时间窗: 90 days
Timeliness of drug administration.
时间窗: 90 days
Feasibility of screening procedures.
时间窗: 90 days
次要结局
- Adverse effects.(90 days)
- Ventilator-free days (number of days alive and breathing unaided within the first 28 days after intubation).(28 days)
- Sedation and analgesia requirements.(90 days)
- Opioid and/or benzodiazepine withdrawal symptoms.(90 days)
- Duration of hospital stay.(90 days)