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