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Colonoscopy may be an unpleasant procedure. Sedation and/or analgesics is therefore routinely administered in most countries. In Norway, however, routine sedation is rare, and medication is normally given on demand, that is, if necessary during the procedure. The investigators want to evaluate whether the effect of fentanyl, a synthetic opioid with fast onset of action, is better given before the procedure than during the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine medication arm | Experimental | Fentanyl is given routinely to all patients before the procedure |
|
| Fentanyl on-demand arm | Active Comparator | Fentanyl is given during the procedure if the patient experiences pain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine medication arm | Drug | 50 micrograms of fentanyl given before the procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain during colonoscopy | Pain is recorded on a 4 point Likert scale and a 100 mm VAS scale. | Immediately after the procedure and after 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Additional medication | The investigators want to assess the need for additional medication during the colonoscopy in the "routine fentanyl-arm" compared to the "fentanyl on-demand arm". | During the colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Patients are asked about satisfaction with information and treatment (yes/no) | The day after the procedure |
| Complications | Sedation-related complications during the procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oyvind Holme, MD | Sorlandet Hospital HF | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sorlandet Hospital Kristiansand | Kristiansand | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27305424 | Derived | Holme O, de Lange T, Stallemo A, Wiig H, Hasund A, Dvergsnes K, Garborg K, Ystrom CM, Loberg M, Hoff G, Bretthauer M, Kalager M. Routine vs. on-demand analgesia in colonoscopy: a randomized clinical trial. Endoscopy. 2016 Sep;48(9):823-8. doi: 10.1055/s-0042-108433. Epub 2016 Jun 15. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Fentanyl on-demand arm | Drug | Fentanyl 50 microgram is provided on-demand, that is, if the patient has pain during the procedure. |
|
|
| During the procedure |
| Caecum intubation time | Time to reach the caecum (minutes) | During the procedure |
| Caecum intubation rate | The number of complete procedures divided by the total number of procedures | During the procedure |
| Willingness to repeat | The patient is asked whether he/she would be willing to have the procedure again in the same way (yes/no). | Within one hour after the procedure |
| Recovery time | Time elapsing between end of procedure until leaving the department | Immediately after the procedure Within one hour after the procedure |