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Optimizing the Use of Entonox® During Screening Colonoscopy

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01865721
Enrollment
100
Registered
2013-05-31
Start date
2013-01-31
Completion date
2014-04-30
Last updated
2019-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Bowel Cancer Screening, Colonoscopy, Entonox

Keywords

Bowel cancer screening, Analgesia, Entonox, Pain, Side effects, Colonoscopy

Brief 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

Interventions

Entonox will be used according to the allocated method

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Having a bowel cancer screening programme colonoscopy

Exclusion criteria

* Contraindications to Entonox * Previous bowel resections

Design outcomes

Primary

MeasureTime frameDescription
Pain scoresDay 1: Prior to discharge from endoscopy departmentPatients will be asked about their overall recollection of pain on a 10 point numerical ratings scale prior to discharge

Secondary

MeasureTime frameDescription
Pain scoresDay 1-4: Prior to discharge and 1-3 days laterPatients 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.
Use of analgesia and sedationDay 1: During colonoscopyPatients additional use of sedation and analgesia will be compared in each treatment arm
Patients satisfactionDay 1-4: Prior to discharge and 1-3 days laterPatients will be asked about their overall level of satisfaction immediately prior to discharge and 1-3 days later
Willingness to have a repeat colonoscopyDay 1: Prior to dischargePatients will be asked about their willingness to have a repeat colonoscopy prior to discharge and 1-3 days following colonoscopy
Side EffectsDay 1: During colonoscopyPatients will be asked about the presence of side effects during colonoscopy. This will be quantified according to whether it limited the use Of Entonox.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026