Effects of Daily Interruption of Sedatives in Critically Ill Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- amount of (near) incidents
研究概览
简要总结
Critically ill children are often sedated in order to relieve them from anxiety and discomfort, and to facilitate their care. There is little information on the effects of prolonged and continuous use of sedatives and analgesic agents in critically ill children. In adult intensive care unit (ICU) patients, daily interruption of sedative infusions accelerates recovery resulting in a reduction in the average duration of mechanical ventilation of 2.4 days as well as a reduction in average ICU length of stay of 3.5 days. These results were achieved without an increased rate of adverse events potentially linked to less sedation and associated with a reduction of common complications of critical illness and without negative psychological effects.
It is unknown whether these results can be extrapolated to critically ill children. Moreover, the possible risk of complications associated with less sedation, such as accidental self-extubation, is probably higher in children. Also, the need for intermittent bolus administrations in children treated with intermittent sedation could nullify the reduction in the use of sedatives.
It is unknown if daily interruption of sedatives is feasible in critically ill children. The researchers studied the effects of daily interruption of sedatives in critically ill children on the total amount of sedatives used and risks of complications.
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
- — 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intubated and mechanically ventilated for > 24 hours
- •Expect further mechanical ventilation for > 48 hours
- •Receiving midazolam and morphine for sedation
- •Written informed consent given by parents
排除标准
- •Inclusion in another trial
- •Transfer from an outside institution where sedatives had been administered
- •Neuromuscular blockers
- •Metabolic disease
- •Neuromuscular disease
- •Encephalopathy
- •Pulmonary hypertension
- •Neurotrauma
- •Raised intracranial pressure
- •Life expectancy less than a month/infaust prognosis
结局指标
主要结局
amount of (near) incidents
时间窗: Until extubation or 28 days
total amount of sedatives administered
时间窗: Until extubation or 28 days
time to wake up (after sedation is stopped), comfort scale
时间窗: Until extubation or 28 days
BIS monitoring
时间窗: Until extubation or 28 days
次要结局
- time on ventilator(Until extubation or 28 days)
- LOS on ICU(Until extubation or 28 days)
