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Completed

NCT Number: NCT01786434

Routine or On-demand Fentanyl in Colonoscopy

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sorlandet Hospital Kristiansand

Kristiansand, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Routine medication arm

Drug

50 micrograms of fentanyl given before the procedure

Other names: fentanyl

Fentanyl on-demand arm

Drug

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

Other names: Fentanyl

Primary outcomes

  1. 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 outcomes

  1. 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".

Other outcomes

  1. Patient satisfaction

    Time frame: The day after the procedure

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

  2. Complications

    Time frame: During the procedure

    Sedation-related complications during the procedure

  3. Caecum intubation time

    Time frame: During the procedure

    Time to reach the caecum (minutes)

  4. Caecum intubation rate

    Time frame: During the procedure

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

  5. 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).

  6. Recovery time

    Time frame: Immediately after the procedure Within one hour after the procedure

    Time elapsing between end of procedure until leaving the department

Sponsors and collaborators

Lead sponsor

Sorlandet Hospital HF

Other Gov

Registry information

Official study title

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

Acronym: FEKOL

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 8, 2013
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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