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Clinical Trials/NCT02407639
NCT02407639CompletedPhase 4

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

University Medical Centre Ljubljana1 site in 1 country78 target enrollmentStarted: March 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
78
Locations
1
Primary Endpoint
to compare post-procedural abdominal pain in children undergoing colonoscopy using CO2 or air for insufflation.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
7 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •indication for colonoscopy

Exclusion Criteria

  • •PM retardation
  • •postprocedural complications regarding sedation

Arms & Interventions

co2 arm

Active Comparator

insufflation with CO2

Intervention: CO2 (Other)

air arm

Placebo Comparator

insufflation with air

Intervention: air (Other)

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tadej Battelino

Prof. Dr.

University Medical Centre Ljubljana

Study Sites (1)

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