Tapering of Analgosedation and Occurrence of Withdrawal Syndrome in Paediatric Intensive Care Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in mean peak WAT-1 score
研究概览
简要总结
The study is a prospective interventional study with three main aims:
- Describe the frequency and severity of withdrawal syndrome in a population of paediatric intensive care patients.
- Test whether implementation of an algorithm for tapering of analgosedation changes the frequency and severity of withdrawal symptoms in the same population.
- Investigate how the health care providers experience having to adhere to such an algorithm.
详细描述
Patients < 18 years of age treated in an intensive care unit for 5 days or more with infusion of opioids and/or benzodiazepines, are eligible for inclusion. Patients are included at the time tapering of these drugs is initiated. Part one of the study is observational. Drugs administered, complications, Comfort score and WAT-1 (Withdrawal Assessment Tool-1) score is recorded. Before part two of the study, an algorithm for tapering of analgosedation is implemented, and the data set is obtained as in part one.
For part three of the study, focus group interviews will be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •< 18 years
- •treated in PICU
- •Infusion of opioids and/or benzodiazepins for 5 days or more.
排除标准
- •Neuromuscular disease
- •Cognitive/neurological disturbance caused by a disease
- •Multiple disabilities
结局指标
主要结局
Change in mean peak WAT-1 score
时间窗: Through study completion, up to 21 days
次要结局
- Ventilator days(Through study completion, up to 21 days)
- Adverse events(Through study completion, up to 21 days)
- Drug doses used(Through study completion, up to 21 days)
- Time used tapering analgosedation(Through study completion, up to 21 days)
- ICU days(Through study completion, up to 21 days)
- Comfort score(Through study completion, up to 21 days)
研究者
Gunnar Bentsen
Consultant
Oslo University Hospital