Optimising the use of Entonox during screening colonoscopy

Phase 1

• Conditions: Colonoscopy; MedDRA version: 14.1 Level: PT Classification code 10010007 Term: Colonoscopy System Organ Class: 10022891 - Investigations; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2012-003342-33-GB
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-24
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 198

Inclusion Criteria

Inclusion criteria are those patients attending for a screening colonoscopy through the Bowel Cancer Screening Programme who wish to start their colonoscopy with Entonox® alone.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 128

Exclusion Criteria

The exclusion criteria are the usual contraindications to the use of Entonox® which include; severe respiratory disease, bullous emphysema, pneumothorax, middle ear disease, sinusitis and recent head injury and previous intolerance.

Other exclusion criteria are a history of previous colectomy / colonic resection, and refusal to enter the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Does continuous use of Entonox® reduce pain severity during colonoscopy?;<br> Secondary Objective: Does continuous use of Entonox® during colonoscopy increase side effects compared to as required?<br> Does continuous use of Entonox® during colonoscopy increase patient satisfaction?<br> Does continuous use of Entonox® during colonoscopy increase willingness to have a repeat colonoscopy?<br> Does continuous use of Entonox® during colonoscopy reduce the need for additional analgesia?<br> ;Primary end point(s): The primary outcome measure will be the recollection of pain during colonoscopy when asked prior to leaving the endoscopy department. Prior to leaving patients will be asked the standard question of ‘between 0 and 10, on average, how much pain have you had during the colonoscopy?’;Timepoint(s) of evaluation of this end point: The time point for this is prior to the patient leaving the endoscopy department.