Insufflation in Children Undergoing Colonoscopy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Colonoscopy, Children

Intervention / Treatment
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* Other: CO2
* Other: air


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: indication for colonoscopy Exclusion Criteria: PM retardation postprocedural complications regarding sedation

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: co2 arm<br>insufflation with CO2 | Other: CO2<br>* gas<br>|
| Placebo Comparator: air arm<br>insufflation with air | Other: air<br>* air<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to compare post-procedural abdominal pain in children undergoing colonoscopy using CO2 or air for insufflation. | 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. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to compare post-procedural girth in children undergoing colonoscopy using CO2 or air for insufflation. | Waist circumferences will be measured before the examination and 10 minutes, and, 2 and 4 hours after the examination. Measurements will be made using tape measure at the level of the umbilicus. | 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insufflation, abdominal pain