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Fentanyl in Colonoscopy

Information source: Sorlandet Hospital HF
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Routine medication arm (Drug); Fentanyl on-demand arm (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Sorlandet Hospital HF

Official(s) and/or principal investigator(s):
Oyvind Holme, MD, Principal Investigator, Affiliation: Sorlandet Hospital HF


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Pain

Secondary outcome: Additional medication


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


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

Locations and Contacts

Sorlandet Hospital Kristiansand, Kristiansand, Norway; Recruiting
Oyvind Holme, MD, Phone: 004738125318, Email: oyvind.holme@sshf.no
Oyvind Holme, MD, Principal Investigator
Additional Information

Starting date: January 2013
Last updated: April 11, 2014

Page last updated: August 23, 2015

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