Routine or On-demand Fentanyl in Colonoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-10

Study Completion Date

2015-07-01

Brief Summary

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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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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Routine medication arm

Fentanyl is given routinely to all patients before the procedure

Group Type EXPERIMENTAL

Routine medication arm

Intervention Type DRUG

50 micrograms of fentanyl given before the procedure

Fentanyl on-demand arm

Fentanyl is given during the procedure if the patient experiences pain

Group Type ACTIVE_COMPARATOR

Fentanyl on-demand arm

Intervention Type DRUG

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

Interventions

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Routine medication arm

50 micrograms of fentanyl given before the procedure

Intervention Type DRUG

Fentanyl on-demand arm

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

Intervention Type DRUG

Other Intervention Names

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fentanyl Fentanyl

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes