Insufflation in Children Undergoing Colonoscopy

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

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.

Study Overview

• Status: Completed
• Conditions: Children; Colonoscopy
• Intervention / Treatment: Other: CO2; Other: air

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 4

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia
    • UMC Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• indication for colonoscopy

Exclusion Criteria:

• PM retardation
• postprocedural complications regarding sedation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: co2 arm; insufflation with CO2	Other: CO2; gas
Placebo Comparator: air arm; insufflation with air	Other: air; air

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Collaborators: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Matjaž Homan, PhD MD, UMC Ljubljana

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 18, 2015
• First Submitted That Met QC Criteria: March 30, 2015
• First Posted (Estimate): April 3, 2015

Study Record Updates

• Last Update Posted (Estimate): December 15, 2015
• Last Update Submitted That Met QC Criteria: December 12, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: abdominal pain; insufflation
• Other Study ID Numbers: CO2vsAIR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No