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Completed

NCT Number: NCT02407639

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.

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Key information

Conditions

Colonoscopy Abdominal Pain Children Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UMC Ljubljana

Ljubljana, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • indication for colonoscopy

Exclusion criteria

  • PM retardation
  • postprocedural complications regarding sedation

Treatment and study plan

CO2

Other

gas

Air

Other

air

Primary outcomes

  1. 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

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

    Time frame: 4 hours

    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.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Collaborators

  • Children's Hospital of Philadelphia

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 3, 2015
Registry last updated
Dec 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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