Optimizing the Use of Entonox® During Screening Colonoscopy
2 other identifiers
interventional
100
1 country
1
Brief Summary
This study will randomise patients undergoing screening colonoscopy to receive Entonox either continuously or as required. Both these methods are used in the published studies of Entonox and in clinical practice. Null hypothesis There will be no difference in pain levels between these two methods of Entonox administration
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 21, 2013
CompletedFirst Posted
Study publicly available on registry
May 31, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedSeptember 23, 2019
September 1, 2019
1.2 years
May 21, 2013
September 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain scores
Patients will be asked about their overall recollection of pain on a 10 point numerical ratings scale prior to discharge
Day 1: Prior to discharge from endoscopy department
Secondary Outcomes (5)
Pain scores
Day 1-4: Prior to discharge and 1-3 days later
Use of analgesia and sedation
Day 1: During colonoscopy
Patients satisfaction
Day 1-4: Prior to discharge and 1-3 days later
Willingness to have a repeat colonoscopy
Day 1: Prior to discharge
Side Effects
Day 1: During colonoscopy
Study Arms (2)
Continuous administration of Entonox
ACTIVE COMPARATORPatients randomized to this arm will be asked to inhale Entonox throughout the insertion phase of colonoscopy
As required administration of Entonox
ACTIVE COMPARATORPatients randomised to this arm will be asked to use Entonox if and when they have pain
Interventions
Entonox will be used according to the allocated method
Eligibility Criteria
You may qualify if:
- Having a bowel cancer screening programme colonoscopy
You may not qualify if:
- Contraindications to Entonox
- Previous bowel resections
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S5 7AU, United Kingdom
Related Publications (1)
Ball AJ, Din S, Donnelly M, Riley SA. A randomized controlled trial comparing continuous and as-required nitrous oxide use during screening colonoscopy. Eur J Gastroenterol Hepatol. 2015 Mar;27(3):271-8. doi: 10.1097/MEG.0000000000000281.
PMID: 25629571DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stuart A Riley, MB ChB
Sheffield Teaching Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2013
First Posted
May 31, 2013
Study Start
January 1, 2013
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
September 23, 2019
Record last verified: 2019-09