Clinical trial NCT02407639: Insufflation in Children Undergoing Colonoscopy
Official title: Randomized, Double-blind Trial of CO2 vs. Air Insufflation in Children Undergoing Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colonoscopy
Children
Keywords: insufflation
abdominal pain
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
First posted: 2015-04-03
Enrollment: 78
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* indication for colonoscopy

Exclusion Criteria:

* PM retardation
* postprocedural complications regarding sedation

Primary outcomes:
measure: to compare post-procedural abdominal pain in children undergoing colonoscopy using CO2 or air for insufflation.
timeFrame: 24 hours
Secondary outcomes:
measure: to compare post-procedural girth in children undergoing colonoscopy using CO2 or air for insufflation.
timeFrame: 4 hours
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: UMC Ljubljana
Study officials:
affiliation: UMC Ljubljana
name: Matjaž Homan, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Homan M, Mahkovic D, Orel R, Mamula P. Randomized, double-blind trial of CO2 versus air insufflation in children undergoing colonoscopy. Gastrointest Endosc. 2016 May;83(5):993-7. doi: 10.1016/j.gie.2015.08.073. Epub 2015 Sep 10.