Routine or On-demand Fentanyl in Colonoscopy

Overview

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.

Full Title of Study: “Routine Versus on Demand Administration of Fentanyl in Colonoscopy: A Multi-centre Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 1, 2015

Interventions

  • Drug: Routine medication arm
    • 50 micrograms of fentanyl given before the procedure
  • Drug: Fentanyl on-demand arm
    • Fentanyl 50 microgram is provided on-demand, that is, if the patient has pain during the procedure.

Arms, Groups and Cohorts

  • Experimental: Routine medication arm
    • Fentanyl is given routinely to all patients before the procedure
  • Active Comparator: Fentanyl on-demand arm
    • Fentanyl is given during the procedure if the patient experiences pain

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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”.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Sorlandet Hospital HF
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Oyvind Holme, MD, Principal Investigator, Sorlandet Hospital HF

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