NCT01865721已完成4 期
Optimizing the Use of Entonox® During Screening Colonoscopy: an Open Randomised Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain scores
研究概览
简要总结
This study will randomise patients undergoing screening colonoscopy to receive Entonox either continuously or as required.
Both these methods are used in the published studies of Entonox and in clinical practice.
Null hypothesis There will be no difference in pain levels between these two methods of Entonox administration
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
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having a bowel cancer screening programme colonoscopy
排除标准
- •Contraindications to Entonox
- •Previous bowel resections
研究组 & 干预措施
Continuous administration of Entonox
Active Comparator
Patients randomized to this arm will be asked to inhale Entonox throughout the insertion phase of colonoscopy
干预措施: Entonox (Drug)
As required administration of Entonox
Active Comparator
Patients randomised to this arm will be asked to use Entonox if and when they have pain
干预措施: Entonox (Drug)
结局指标
主要结局
Pain scores
时间窗: Day 1: Prior to discharge from endoscopy department
Patients will be asked about their overall recollection of pain on a 10 point numerical ratings scale prior to discharge
次要结局
- Willingness to have a repeat colonoscopy(Day 1: Prior to discharge)
- Pain scores(Day 1-4: Prior to discharge and 1-3 days later)
- Use of analgesia and sedation(Day 1: During colonoscopy)
- Patients satisfaction(Day 1-4: Prior to discharge and 1-3 days later)
- Side Effects(Day 1: During colonoscopy)
研究者
研究点 (1)
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