NCT02407639

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 15, 2015

Status Verified

December 1, 2015

Enrollment Period

9 months

First QC Date

March 18, 2015

Last Update Submit

December 12, 2015

Conditions

ColonoscopyChildren

Keywords

insufflationabdominal pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    4 hours

Study Arms (2)

co2 arm

ACTIVE COMPARATOR

insufflation with CO2

Other: CO2

air arm

PLACEBO COMPARATOR

insufflation with air

Other: air

Interventions

CO2OTHER

gas

co2 arm
airOTHER

air

air arm

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • indication for colonoscopy

You may not qualify if:

  • PM retardation
  • postprocedural complications regarding sedation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Ljubljana

Ljubljana, Slovenia

Location

Related Publications (1)

  • 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.

    PMID: 26363332DERIVED

MeSH Terms

Conditions

Abdominal Pain

Interventions

Air

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

AtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public Health

Study Officials

  • Matjaž Homan, PhD MD

    UMC Ljubljana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

March 18, 2015

First Posted

April 3, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 15, 2015

Record last verified: 2015-12

Locations

SL(1)