Routine or On-demand Fentanyl in Colonoscopy (FEKOL)

March 25, 2022 updated by: Sorlandet Hospital HF

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Kristiansand, Norway
        • Sorlandet Hospital Kristiansand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Routine medication arm
Fentanyl is given routinely to all patients before the procedure
Drug: Routine medication arm
50 micrograms of fentanyl given before the procedure
Other Names:
  • fentanyl
ACTIVE_COMPARATOR: Fentanyl on-demand arm
Fentanyl is given during the procedure if the patient experiences pain
Drug: Fentanyl on-demand arm
Fentanyl 50 microgram is provided on-demand, that is, if the patient has pain during the procedure.
Other Names:
  • Fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain during colonoscopy
Time Frame: Immediately after the procedure and after 24 hours
Pain is recorded on a 4 point Likert scale and a 100 mm VAS scale.
Immediately after the procedure and after 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Additional medication
Time Frame: During the colonoscopy
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: The day after the procedure
Patients are asked about satisfaction with information and treatment (yes/no)
The day after the procedure
Complications
Time Frame: During the procedure
Sedation-related complications during the procedure
During the procedure
Caecum intubation time
Time Frame: During the procedure
Time to reach the caecum (minutes)
During the procedure
Caecum intubation rate
Time Frame: During the procedure
The number of complete procedures divided by the total number of procedures
During the procedure
Willingness to repeat
Time Frame: Within one hour after the procedure
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 Frame: Immediately after the procedure Within one hour after the procedure
Time elapsing between end of procedure until leaving the department
Immediately after the procedure Within one hour after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sorlandet Hospital HF

Investigators

  • Principal Investigator: Oyvind Holme, MD, Sorlandet Hospital HF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 10, 2012

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

January 3, 2013

First Submitted That Met QC Criteria

February 7, 2013

First Posted (ESTIMATE)

February 8, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 6, 2022

Last Update Submitted That Met QC Criteria

March 25, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/1737

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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