Routine or On-demand Fentanyl in Colonoscopy

Pain Clinical Trial

— FEKOL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01786434
• Other study ID #: 2012/1737
• Status: Completed
• Phase: N/A
• Start date: December 10, 2012
• Est. completion date: July 1, 2015

Study information

• Verified date: March 2022
• Source: Sorlandet Hospital HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: July 1, 2015
• Est. primary completion date: July 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Routine medication arm
50 micrograms of fentanyl given before the procedure
• Fentanyl on-demand arm
Fentanyl 50 microgram is provided on-demand, that is, if the patient has pain during the procedure.

Locations

Country	Name	City	State
Norway	Sorlandet Hospital Kristiansand	Kristiansand

Sponsors (1)

Lead Sponsor	Collaborator
Sorlandet Hospital HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient satisfaction	Patients are asked about satisfaction with information and treatment (yes/no)	The day after the procedure
Other	Complications	Sedation-related complications during the procedure	During the procedure
Other	Caecum intubation time	Time to reach the caecum (minutes)	During the procedure
Other	Caecum intubation rate	The number of complete procedures divided by the total number of procedures	During the procedure
Other	Willingness to repeat	The patient is asked whether he/she would be willing to have the procedure again in the same way (yes/no).	Within one hour after the procedure
Other	Recovery time	Time elapsing between end of procedure until leaving the department	Immediately after the procedure Within one hour after the procedure
Primary	Pain during colonoscopy	Pain is recorded on a 4 point Likert scale and a 100 mm VAS scale.	Immediately after the procedure and after 24 hours
Secondary	Additional medication	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".	During the colonoscopy