Optimizing the Use of Entonox® During Screening Colonoscopy

Phase 4

Completed

• Conditions: Bowel Cancer Screening; Entonox; Colonoscopy; Analgesia
• Interventions: Drug: Entonox

• Registration Number: NCT01865721
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-05-21
• Study First Submitted QC: 2013-05-28
• Study First Posted: 2013-05-31
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-19
• Last Update Posted: 2019-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Having a bowel cancer screening programme colonoscopy

Exclusion Criteria

• Contraindications to Entonox
• Previous bowel resections

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous administration of Entonox	Entonox	Patients randomized to this arm will be asked to inhale Entonox throughout the insertion phase of colonoscopy
As required administration of Entonox	Entonox	Patients randomised to this arm will be asked to use Entonox if and when they have pain

Primary Outcome Measures

Name	Time	Method
Pain scores	Day 1: Prior to discharge from endoscopy department	Patients will be asked about their overall recollection of pain on a 10 point numerical ratings scale prior to discharge

Secondary Outcome Measures

Name	Time	Method
Willingness to have a repeat colonoscopy	Day 1: Prior to discharge	Patients will be asked about their willingness to have a repeat colonoscopy prior to discharge and 1-3 days following colonoscopy
Pain scores	Day 1-4: Prior to discharge and 1-3 days later	Patients will be asked about their experience of pain during colonoscopy. In addition patients will be asked about their overall recollection of pain immediately after colonoscopy and 1-3 days following colonoscopy.
Use of analgesia and sedation	Day 1: During colonoscopy	Patients additional use of sedation and analgesia will be compared in each treatment arm
Patients satisfaction	Day 1-4: Prior to discharge and 1-3 days later	Patients will be asked about their overall level of satisfaction immediately prior to discharge and 1-3 days later
Side Effects	Day 1: During colonoscopy	Patients will be asked about the presence of side effects during colonoscopy. This will be quantified according to whether it limited the use Of Entonox.

Trial Locations

Locations (1)

Sheffield Teaching Hospitals NHS Foundation Trust; 🇬🇧 Sheffield, South Yorkshire, United Kingdom