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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003342-33 | EudraCT Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous administration of Entonox | Active Comparator | Patients randomized to this arm will be asked to inhale Entonox throughout the insertion phase of colonoscopy |
|
| As required administration of Entonox | Active Comparator | Patients randomised to this arm will be asked to use Entonox if and when they have pain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entonox | Drug | Entonox will be used according to the allocated method |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart A Riley, MB ChB | Sheffield Teaching Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | South Yorkshire | S5 7AU | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25629571 | Derived | Ball AJ, Din S, Donnelly M, Riley SA. A randomized controlled trial comparing continuous and as-required nitrous oxide use during screening colonoscopy. Eur J Gastroenterol Hepatol. 2015 Mar;27(3):271-8. doi: 10.1097/MEG.0000000000000281. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C001147 | Entonox |
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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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |