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Insufflation in Children Undergoing Colonoscopy

U

University Medical Centre Ljubljana

Status and phase

Completed
Phase 4

Conditions

Children
Colonoscopy

Treatments

Other: CO2
Other: air

Study type

Interventional

Funder types

Other

Identifiers

NCT02407639
CO2vsAIR

Details and patient eligibility

About

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.

Full 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.

Enrollment

78 patients

Sex

All

Ages

7 to 18 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • indication for colonoscopy

Exclusion criteria

  • PM retardation
  • postprocedural complications regarding sedation

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

78 participants in 2 patient groups, including a placebo group

co2 arm
Active Comparator group
Description:
insufflation with CO2
Treatment:
Other: CO2
air arm
Placebo Comparator group
Description:
insufflation with air
Treatment:
Other: air

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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