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临床试验/NCT00441506
NCT00441506已完成不适用

Effects of Daily Interruption of Sedatives in Critically Ill Children

Radboud University Medical Center2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2004年11月最近更新:
适应症
相关药物

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

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)

研究者

申办方类型
Other

研究点 (2)

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