Routine or On-demand Fentanyl in Colonoscopy (FEKOL)

S

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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