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Routine or On-demand Fentanyl in Colonoscopy

Routine Versus on Demand Administration of Fentanyl in Colonoscopy: A Multi-centre Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01786434
Acronym
FEKOL
Enrollment
119
Registered
2013-02-08
Start date
2012-12-10
Completion date
2015-07-01
Last updated
2022-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

colonoscopy, pain

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.

Interventions

DRUGRoutine medication arm

50 micrograms of fentanyl given before the procedure

DRUGFentanyl on-demand arm

Fentanyl 50 microgram is provided on-demand, that is, if the patient has pain during the procedure.

Sponsors

Sorlandet Hospital HF
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pain during colonoscopyImmediately after the procedure and after 24 hoursPain is recorded on a 4 point Likert scale and a 100 mm VAS scale.

Secondary

MeasureTime frameDescription
Additional medicationDuring the colonoscopyThe investigators want to assess the need for additional medication during the colonoscopy in the routine fentanyl-arm compared to the fentanyl on-demand arm.

Other

MeasureTime frameDescription
Caecum intubation timeDuring the procedureTime to reach the caecum (minutes)
Caecum intubation rateDuring the procedureThe number of complete procedures divided by the total number of procedures
Patient satisfactionThe day after the procedurePatients are asked about satisfaction with information and treatment (yes/no)
Recovery timeImmediately after the procedure Within one hour after the procedureTime elapsing between end of procedure until leaving the department
Willingness to repeatWithin one hour after the procedureThe patient is asked whether he/she would be willing to have the procedure again in the same way (yes/no).
ComplicationsDuring the procedureSedation-related complications during the procedure

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026