Optimizing the Use of Entonox® During Screening Colonoscopy

Study Overview
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Brief Summary
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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 Title
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Optimizing the Use of Entonox® During Screening Colonoscopy: an Open Randomised Controlled Trial

Conditions
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Bowel Cancer Screening, Analgesia, Entonox, Colonoscopy

Intervention / Treatment
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* Drug: Entonox


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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous administration of Entonox<br>Patients randomized to this arm will be asked to inhale Entonox throughout the insertion phase of colonoscopy | Drug: Entonox<br>* Entonox will be used according to the allocated method<br>|
| Active Comparator: As required administration of Entonox<br>Patients randomised to this arm will be asked to use Entonox if and when they have pain | Drug: Entonox<br>* Entonox will be used according to the allocated method<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Use of analgesia and sedation | Patients additional use of sedation and analgesia will be compared in each treatment arm | 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 | 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 | 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. | Day 1: During colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bowel cancer screening, Analgesia, Entonox, Pain, Side effects, Colonoscopy