PainFEKOLNCT01786434
Routine or On-demand Fentanyl in Colonoscopy
A study testing Routine medication arm and Fentanyl on-demand arm in people with Pain, run by Sorlandet Hospital HF at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Routine medication arm and Fentanyl on-demand arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteNorway
- Study dates
- 10 Dec 2012to 1 Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-75
- Referred for out-patient colonoscopy
Who cannot join
- ASA-score 3 or higher
- Same day upper endoscopy
- Pregnancy
- Pacemaker
- Patient require medication before colonoscopy
- Previous resection of colon or rectum
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Routine Versus on Demand Administration of Fentanyl in Colonoscopy: A Multi-centre Randomized Controlled Trial
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.
- Conditions
- Pain
- Being tested
- Routine medication arm, Fentanyl on-demand arm
- Keywords
- colonoscopy, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine medication armDrug
Also called fentanyl
50 micrograms of fentanyl given before the procedure
Fentanyl on-demand armDrug
Also called Fentanyl
Fentanyl 50 microgram is provided on-demand, that is, if the patient has pain during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Routine medication arm | Experimental | Fentanyl is given routinely to all patients before the procedure Receives: Drug: Routine medication arm |
| Fentanyl on-demand arm | Active comparator | Fentanyl is given during the procedure if the patient experiences pain Receives: Drug: Fentanyl on-demand arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during colonoscopy
Pain is recorded on a 4 point Likert scale and a 100 mm VAS scale.
Measured: Immediately after the procedure and after 24 hours
Secondary outcomes (1)
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".
Measured: During the colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study start10 Dec 2012
- Primary completion1 Jul 2015
- Study completion1 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Oyvind Holme, MD, Principal investigator, Sorlandet Hospital HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786434
- Sponsor's protocol ID
- 2012/1737
- Acronym
- FEKOL
- Status last verified
- Mar 2022
- First submitted
- 3 Jan 2013
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Holme O, de Lange T, Stallemo A, Wiig H, Hasund A, Dvergsnes K, Garborg K, Ystrom CM, Loberg M, Hoff G, Bretthauer M, Kalager M. Routine vs. on-demand analgesia in colonoscopy: a randomized clinical trial. Endoscopy. 2016 Sep;48(9):823-8. doi: 10.1055/s-0042-108433. Epub 2016 Jun 15.
PubMed 27305424
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Versus on Demand Administration of Fentanyl in Colonoscopy: A Multi-centre Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01786434
- Acronym / sponsor ID
- FEKOL / 2012/1737
- Conditions
- Pain
- Keywords
- colonoscopy, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Study start
- 10 Dec 2012 (actual)
- Primary completion
- 1 Jul 2015 (actual)
- Study completion
- 1 Jul 2015 (actual)
- First posted
- 8 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine medication arm | Experimental | Drug: Routine medication armFentanyl is given routinely to all patients before the procedure |
| Fentanyl on-demand arm | Active comparator | Drug: Fentanyl on-demand armFentanyl is given during the procedure if the patient experiences pain |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-75
- Referred for out-patient colonoscopy
Key exclusion criteria (11 listed)
- ASA-score 3 or higher
- Same day upper endoscopy
- Pregnancy
- Pacemaker
- Patient require medication before colonoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine medication armAlso: fentanyl50 micrograms of fentanyl given before the procedure | Drug | Routine medication arm |
| Fentanyl on-demand armAlso: FentanylFentanyl 50 microgram is provided on-demand, that is, if the patient has pain during the procedure. | Drug | Fentanyl on-demand arm |
Primary outcome
Pain during colonoscopy
Time frame: Immediately after the procedure and after 24 hours
Pain is recorded on a 4 point Likert scale and a 100 mm VAS scale.
1 secondary outcome
Additional medication
Time frame: During the colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Derived from this study: PubMed 27305424Holme O, de Lange T, Stallemo A, Wiig H, Hasund A, Dvergsnes K, Garborg K, Ystrom CM, Loberg M, Hoff G, Bretthauer M, Kalager M. Routine vs. on-demand analgesia in colonoscopy: a randomized clinical trial. Endoscopy. 2016 Sep;48(9):823-8. doi: 10.1055/s-0042-108433. Epub 2016 Jun 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oyvind Holme, MD principal investigator
Sorlandet Hospital HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine medication arm and Fentanyl on-demand arm in people with Pain, run by Sorlandet Hospital HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during colonoscopy (time frame: Immediately after the procedure and after 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01786434, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.