Optimizing the Use of Entonox® During Screening Colonoscopy

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01865721
• Other study ID #: STH16359
• Secondary ID: 2012-003342-33
• Status: Completed
• Phase: Phase 4
• Start date: January 2013
• Est. completion date: April 2014

Study information

• Verified date: September 2019
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

Inclusion Criteria:

• Having a bowel cancer screening programme colonoscopy

Exclusion Criteria:

• Contraindications to Entonox

• Previous bowel resections

Related Conditions & MeSH terms

• Analgesia
• Bowel Cancer Screening
• Colonoscopy
• Entonox

Intervention

Drug:
• Entonox
Entonox will be used according to the allocated method

Locations

Country	Name	City	State
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield	South Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Use of analgesia and sedation	Patients additional use of sedation and analgesia will be compared in each treatment arm	Day 1: During colonoscopy
Secondary	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
Secondary	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
Secondary	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