Routine or On-demand Fentanyl in Colonoscopy
FEKOL
Routine Versus on Demand Administration of Fentanyl in Colonoscopy: A Multi-centre Randomized Controlled Trial
1 other identifier
interventional
119
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Dec 2012
Longer than P75 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 10, 2012
CompletedFirst Submitted
Initial submission to the registry
January 3, 2013
CompletedFirst Posted
Study publicly available on registry
February 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedApril 6, 2022
March 1, 2022
2.6 years
January 3, 2013
March 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Additional medication
During the colonoscopy
Other Outcomes (6)
Patient satisfaction
The day after the procedure
Complications
During the procedure
Caecum intubation time
During the procedure
- +3 more other outcomes
Study Arms (2)
Routine medication arm
EXPERIMENTALFentanyl is given routinely to all patients before the procedure
Fentanyl on-demand arm
ACTIVE COMPARATORFentanyl is given during the procedure if the patient experiences pain
Interventions
50 micrograms of fentanyl given before the procedure
Fentanyl 50 microgram is provided on-demand, that is, if the patient has pain during the procedure.
Eligibility Criteria
You may qualify if:
- Age 18-75
- Referred for out-patient colonoscopy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sorlandet Hospital Kristiansand
Kristiansand, Norway
Related Publications (1)
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.
PMID: 27305424DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oyvind Holme, MD
Sorlandet Hospital HF
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2013
First Posted
February 8, 2013
Study Start
December 10, 2012
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
April 6, 2022
Record last verified: 2022-03