Routine Versus on Demand Administration of Fentanyl in Colonoscopy: A Multi-centre Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Pain during colonoscopy
研究概览
简要总结
Colonoscopy may be an unpleasant procedure. Sedation and/or analgesics is therefore routinely administered in most countries. In Norway, however, routine sedation is rare, and medication is normally given on demand, that is, if necessary during the procedure. The investigators want to evaluate whether the effect of fentanyl, a synthetic opioid with fast onset of action, is better given before the procedure than during the procedure.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-75
- •Referred for out-patient colonoscopy
排除标准
- •ASA-score 3 or higher
- •Same day upper endoscopy
- •Pregnancy
- •Pacemaker
- •Patient require medication before colonoscopy
- •Previous resection of colon or rectum
- •Significant psychiatric morbidity
- •Oxygen saturation < 95% without supplementary oxygen
- •Contra indications to fentanyl
- •Inability to sign inform consent
- •Inability to understand information about the trial
研究组 & 干预措施
Routine medication arm
Fentanyl is given routinely to all patients before the procedure
干预措施: Routine medication arm (Drug)
Fentanyl on-demand arm
Fentanyl is given during the procedure if the patient experiences pain
干预措施: Fentanyl on-demand arm (Drug)
结局指标
主要结局
Pain during colonoscopy
时间窗: Immediately after the procedure and after 24 hours
Pain is recorded on a 4 point Likert scale and a 100 mm VAS scale.
次要结局
- Additional medication(During the colonoscopy)