NCT02324413已完成3 期
Randomised Controlled Pilot Study: Does Intraoperative Clonidine Reduce the Incidence of Post-hospitalisation Negative Behaviour Changes in Children Who Are Distressed During the Induction of General Anaesthesia?
Richard Beringer1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2013年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Number of negative changes on the post-hospitalization behavior questionnaire
研究概览
简要总结
Children who are upset during induction of general anaesthesia are frequently distressed postoperatively and are more likely to demonstrate negative behaviour changes.
This pilot study is a randomised controlled study of clonidine vs placebo during anaesthesia to identify whether postoperative behavioural disturbance may be minimised.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 2 to 10 years inclusive
- •healthy (ASA 1 or 2)
排除标准
- •inability of parents to understand english
研究组 & 干预措施
clonidine
Active Comparator
Clonidine intravenous 1 or 2 micrograms / kg
干预措施: Clonidine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of negative changes on the post-hospitalization behavior questionnaire
时间窗: 24 hours and 7 days
次要结局
未报告次要终点
研究者
Richard Beringer
Dr
University Hospitals Bristol and Weston NHS Foundation Trust
研究点 (1)
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