Routine or On-demand Fentanyl in Colonoscopy

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: Fentanyl on-demand arm; Drug: Routine medication arm

• Registration Number: NCT01786434
• Lead Sponsor: Sorlandet Hospital HF

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-10
• Study First Submitted: 2013-01-03
• Study First Submitted QC: 2013-02-07
• Study First Posted: 2013-02-08
• Primary Completion: 2015-07-01
• Study Completion: 2015-07-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-25
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fentanyl on-demand arm	Fentanyl on-demand arm	Fentanyl is given during the procedure if the patient experiences pain
Routine medication arm	Routine medication arm	Fentanyl is given routinely to all patients before the procedure

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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".

Trial Locations

Locations (1)

Sorlandet Hospital Kristiansand; 🇳🇴 Kristiansand, Norway