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FEKOL: Routine or On-demand Fentanyl in Colonoscopy

Sponsor
Sorlandet Hospital HF (Other)
Overall Status
Completed
CT.gov ID
NCT01786434
Collaborator
(none)
119
Enrollment
1
Location
2
Arms
30.7
Actual Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Routine medication arm
  • Drug: Fentanyl on-demand arm
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
119 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Routine Versus on Demand Administration of Fentanyl in Colonoscopy: A Multi-centre Randomized Controlled Trial
Actual Study Start Date :
Dec 10, 2012
Actual Primary Completion Date :
Jul 1, 2015
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain during colonoscopy [Immediately after the procedure and after 24 hours]

      Pain is recorded on a 4 point Likert scale and a 100 mm VAS scale.

    Secondary Outcome Measures

    1. Additional medication [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".

    Other Outcome Measures

    1. Patient satisfaction [The day after the procedure]

      Patients are asked about satisfaction with information and treatment (yes/no)

    2. Complications [During the procedure]

      Sedation-related complications during the procedure

    3. Caecum intubation time [During the procedure]

      Time to reach the caecum (minutes)

    4. Caecum intubation rate [During the procedure]

      The number of complete procedures divided by the total number of procedures

    5. Willingness to repeat [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).

    6. Recovery time [Immediately after the procedure Within one hour after the procedure]

      Time elapsing between end of procedure until leaving the department

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sorlandet Hospital Kristiansand Kristiansand Norway

    Sponsors and Collaborators

    • Sorlandet Hospital HF

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sorlandet Hospital HF
    ClinicalTrials.gov Identifier:
    NCT01786434
    Other Study ID Numbers:
    • 2012/1737
    First Posted:
    Feb 8, 2013
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Mar 1, 2022
    Keywords provided by Sorlandet Hospital HF
    colonoscopy
    pain
    Additional relevant MeSH terms:
    Fentanyl

    Study Results

    No Results Posted as of Apr 6, 2022