Optimizing the Use of Entonox® During Screening Colonoscopy

Sheffield Teaching Hospitals NHS Foundation Trust100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Bowel Cancer Screening Analgesia Entonox Colonoscopy

Interventions

EntonoxDRUG

Entonox will be used according to the allocated method

Eligibility

Sex: ALLMin age: 60 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Having a bowel cancer screening programme colonoscopy Exclusion Criteria: * Contraindications to Entonox * Previous bowel resections

Locations (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, United Kingdom

Outcomes

Primary Outcomes

Pain scores

Patients will be asked about their overall recollection of pain on a 10 point numerical ratings scale prior to discharge

Time frame: Day 1: Prior to discharge from endoscopy department

Secondary Outcomes

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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: Day 1: During colonoscopy

Data from ClinicalTrials.gov

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