Optimizing the Use of Entonox® During Screening Colonoscopy

NHS Foundation Trust

Status and phase: Completed; Phase 4

Conditions: Entonox; Bowel Cancer Screening; Colonoscopy; Analgesia

Treatments: Drug: Entonox

Study type: Interventional

Funder types: Other

Identifiers

NCT01865721

STH16359

2012-003342-33 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 60 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Having a bowel cancer screening programme colonoscopy

Exclusion criteria

• Contraindications to Entonox
• Previous bowel resections

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Continuous administration of Entonox

Active Comparator group

Description:

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

Treatment:

Drug: Entonox

As required administration of Entonox

Active Comparator group

Description:

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

Treatment:

Drug: Entonox