Optimizing the Use of Entonox® During Screening Colonoscopy

Optimizing the Use of Entonox® During Screening Colonoscopy: an Open Randomised Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Analgesia; Colonoscopy; Bowel Cancer Screening; Entonox
• Intervention / Treatment: Drug: Entonox

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S5 7AU
      • Sheffield Teaching Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Having a bowel cancer screening programme colonoscopy

Exclusion Criteria:

• Contraindications to Entonox
• Previous bowel resections

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Continuous administration of Entonox; Patients randomized to this arm will be asked to inhale Entonox throughout the insertion phase of colonoscopy	Drug: Entonox; Entonox will be used according to the allocated method
ACTIVE_COMPARATOR: As required administration of Entonox; Patients randomised to this arm will be asked to use Entonox if and when they have pain	Drug: Entonox; Entonox will be used according to the allocated method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	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.	Day 1-4: Prior to discharge and 1-3 days later
Use of analgesia and sedation	Patients additional use of sedation and analgesia will be compared in each treatment arm	Day 1: During colonoscopy
Patients satisfaction	Patients will be asked about their overall level of satisfaction immediately prior to discharge and 1-3 days later	Day 1-4: Prior to discharge and 1-3 days later
Willingness to have a repeat colonoscopy	Patients will be asked about their willingness to have a repeat colonoscopy prior to discharge and 1-3 days following colonoscopy	Day 1: Prior to discharge
Side Effects	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.	Day 1: During colonoscopy

Collaborators and Investigators

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Stuart A Riley, MB ChB, Sheffield Teaching Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): April 1, 2014
• Study Completion (ACTUAL): April 1, 2014

Study Registration Dates

• First Submitted: May 21, 2013
• First Submitted That Met QC Criteria: May 28, 2013
• First Posted (ESTIMATE): May 31, 2013

Study Record Updates

• Last Update Posted (ACTUAL): September 23, 2019
• Last Update Submitted That Met QC Criteria: September 19, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Pain; Analgesia; Colonoscopy; Side effects; Entonox; Bowel cancer screening
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics; Anesthetics, Combined; Entonox
• Other Study ID Numbers: STH16359; 2012-003342-33 (EUDRACT_NUMBER)