Fentanyl in Colonoscopy
This trial is active, not recruiting.
|Treatments||routine medication arm, fentanyl on-demand arm|
|Sponsor||Sorlandet Hospital HF|
|Start date||January 2013|
|End date||January 2017|
|Trial size||119 participants|
|Trial identifier||NCT01786434, 2012/1737|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
time frame: Immediately after the procedure and after 24 hours
time frame: During the colonoscopy
Male or female participants from 18 years up to 75 years old.
Inclusion Criteria: - Age 18-75 - Referred for out-patient colonoscopy Exclusion Criteria: - ASA-score 3 or higher - Same day upper endoscopy - Pregnancy - Pacemaker - Patient require medication before colonoscopy - Previous resection of colon or rectum - Significant psychiatric morbidity - Oxygen saturation < 95% without supplementary oxygen - Contra indications to fentanyl - Inability to sign inform consent - Inability to understand information about the trial
|Official title||Routine Versus on Demand Administration of Fentanyl in Colonoscopy: A Multi-centre Randomized Controlled Trial|
|Principal investigator||Oyvind Holme, MD|
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