Routine or On-demand Fentanyl in Colonoscopy (FEKOL)

Sorlandet Hospital HF

Status: Completed

Conditions: Pain

Treatments: Drug: Fentanyl on-demand arm; Drug: Routine medication arm

Study type: Interventional

Funder types: Other

Identifiers

NCT01786434

2012/1737

Details and patient eligibility

About

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.

Enrollment: 119 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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119 participants in 2 patient groups

Routine medication arm

Experimental group

Description:

Fentanyl is given routinely to all patients before the procedure

Treatment:

Drug: Routine medication arm

Fentanyl on-demand arm

Active Comparator group

Description:

Fentanyl is given during the procedure if the patient experiences pain

Treatment:

Drug: Fentanyl on-demand arm