Completed

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

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What is being tested

Entonox

Drug
Who is being recruted

Agnosia+5

+ Nervous System Diseases

+ Neurologic Manifestations

From 60 to 75 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: January 2013
See protocol details

Summary

Principal SponsorSheffield Teaching Hospitals NHS Foundation Trust
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

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

Official TitleOptimizing the Use of Entonox® During Screening Colonoscopy: an Open Randomised Controlled Trial
NCT01865721
Principal SponsorSheffield Teaching Hospitals NHS Foundation Trust
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 60 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AgnosiaNervous System DiseasesNeurologic ManifestationsPainPerceptual DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral Manifestations

Criteria

1 inclusion criteria required to participate
Having a bowel cancer screening programme colonoscopy
2 exclusion criteria prevent from participating
Contraindications to Entonox
Previous bowel resections

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Patients randomised to this arm will be asked to use Entonox if and when they have pain

Group II

Active Comparator
Patients randomized to this arm will be asked to inhale Entonox throughout the insertion phase of colonoscopy

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United KingdomOpen Sheffield Teaching Hospitals NHS Foundation Trust in Google Maps
CompletedOne Study Center