This trial is active, not recruiting.

Condition pain
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Fentanyl is given routinely to all patients before the procedure
routine medication arm fentanyl
50 micrograms of fentanyl given before the procedure
(Active Comparator)
Fentanyl is given during the procedure if the patient experiences pain
fentanyl on-demand arm Fentanyl
Fentanyl 50 microgram is provided on-demand, that is, if the patient has pain during the procedure.

Primary Outcomes

time frame: Immediately after the procedure and after 24 hours

Secondary Outcomes

Additional medication
time frame: During the colonoscopy

Eligibility Criteria

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

Additional Information

Official title Routine Versus on Demand Administration of Fentanyl in Colonoscopy: A Multi-centre Randomized Controlled Trial
Principal investigator Oyvind Holme, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Sorlandet Hospital HF.