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Insufflation in Children Undergoing Colonoscopy

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ClinicalTrials.gov Identifier: NCT02407639
Recruitment Status : Completed
First Posted : April 3, 2015
Last Update Posted : December 15, 2015
Sponsor:
Collaborator:
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
Tadej Battelino, University Medical Centre Ljubljana

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.

Condition or disease Intervention/treatment Phase
Colonoscopy Children Other: CO2 Other: air Phase 4

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  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Randomized, Double-blind Trial of CO2 vs. Air Insufflation in Children Undergoing Colonoscopy
Study Start Date : March 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: co2 arm
insufflation with CO2
Other: CO2
gas

Placebo Comparator: air arm
insufflation with air
Other: air
air




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • indication for colonoscopy

Exclusion Criteria:

  • PM retardation
  • postprocedural complications regarding sedation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02407639


Locations
Slovenia
UMC Ljubljana
Ljubljana, Slovenia
Sponsors and Collaborators
University Medical Centre Ljubljana
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Matjaž Homan, PhD MD UMC Ljubljana

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tadej Battelino, Prof. Dr., University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02407639     History of Changes
Other Study ID Numbers: CO2vsAIR
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015

Keywords provided by Tadej Battelino, University Medical Centre Ljubljana:
insufflation
abdominal pain