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临床试验/NCT02407639
NCT02407639已完成4 期

Randomized, Double-blind Trial of CO2 vs. Air Insufflation in Children Undergoing Colonoscopy

University Medical Centre Ljubljana1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
78
试验地点
1
主要终点
to compare post-procedural abdominal pain in children undergoing colonoscopy using CO2 or air for insufflation.

研究概览

简要总结

Studies in adults have shown that post-procedural abdominal pain is reduced with the use of CO2 instead of air for insufflation during colonoscopy. The aim of our study is to compare post-procedural abdominal pain and girth in children undergoing colonoscopy using CO2 or air for insufflation.

详细描述

Several prospective studies in adults have confirmed the efficacy and safety of CO2 insufflation in comparison with atmospheric air insufflation during colonoscopy. CO2 insufflation was associated with decreased post-procedural abdominal pain, which likely stems from the fact that, in comparison to air, absorption of CO2 from the colon is much faster due to a much greater water solubility. Animal studies have also shown that CO2 insufflation results in less disturbance of parietal blood flow due to its potential vasodilating effect. Insufflation of colon with CO2 did not prolong the procedure or lengthen the time to reach the terminal ileum and was proven to be safe in both sedated and non-sedated patients . The use of CO2 for colon insufflation could possibly lead to CO2 retention and increased levels in the blood thus interfering with acid-base balance . However, previous studies reported that carbon dioxide insufflation did not cause increased CO2 levels in the blood or end-tidal CO2 (ETCO2) and complication rates were not increased when using CO2. Because of its advantages CO2 insufflation has become a standard of care in adult colonoscopy.

To the best of our knowledge there are so far no published reports comparing CO2 and air insufflation during colonoscopy in children.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
7 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • indication for colonoscopy

排除标准

  • PM retardation
  • postprocedural complications regarding sedation

结局指标

主要结局

to compare post-procedural abdominal pain in children undergoing colonoscopy using CO2 or air for insufflation.

时间窗: 24 hours

NRS-11 pain scale will be used to assess abdominal pain, ranging from "no pain" marked as 0 point to "worst pain ever" marked as 10 points. Children will be asked to score the amount of pain experienced at 2, 4, and 24 hours after the examination.

次要结局

  • to compare post-procedural girth in children undergoing colonoscopy using CO2 or air for insufflation.(4 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tadej Battelino

Prof. Dr.

University Medical Centre Ljubljana

研究点 (1)

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