HealthyFentaOIH-VNCT02252458
Can Fentanyl Lead to Opioid-induced Hyperalgesia in Healthy Volunteers?
A study testing Fentanyl in people with Healthy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The purpose of this study is to examine whether two clinically sensible dose regimen of fentanyl (low dose vs. high dose) lead to different pain scores as measured by the nonverbal rating scale (NRS) in healthy volunteers at 4.5 to 6.5 hours after fentanyl application. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2014to Jan 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy (ASA I-II) male volunteers
- Age > 18 years
- BMI 18 - 25 kg/m2
Who cannot join
- Volunteers unable to give written informed consent
- Known drug allergies or intolerance to fentanyl
- Known drug allergies or intolerance to morphine and other opiates
- Recreational drug addiction or abuse
- Opiate use in the last month
- Volunteers taking confounding medication (analgesics, antihistamines, calcium or potassium channel blockers) in the last month
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- History of motion sickness, neuropathy, chronic pain, neuromuscular or psychiatric disease
- Patients with renal failure (clearance < 30 ml/min)
- obstructive sleep apnea syndrome (OSAS)
- Indication for Rapid Sequence Induction
- Patients not understanding German, French, Italian or English
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Anesthesia, University of Basel Hospital
Basel, 4031
About this study
Official title: Can Fentanyl Lead to Opioid-induced Hyperalgesia in Healthy Volunteers? A Prospective, Randomized, Double-blinded Crossover Study
The purpose of this study is to examine whether two clinically sensible dose regimen of fentanyl (low dose vs. high dose) lead to different pain scores as measured by the nonverbal rating scale (NRS) in healthy volunteers at 4.5 to 6.5 hours after fentanyl application. Pain modalities tested will include transdermal electrical stimulation and cold pressor pain.
The investigators hypothesize that the high dose fentanyl group will have an increase of approximately 20% in the NRS.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl high dose | Experimental | Fentanyl 10mcg/kg of bodyweight Receives: Drug: Fentanyl |
| Fentanyl low dose | Active comparator | Fentanyl 1mcg/kg of bodyweight Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
COMPOSITE of pain scores as measured by the nonverbal rating scale (NRS) at 15 minute intervals within the timeframe specified below.
Measured: 4.5 to 6.5h after begin of fentanyl infusion
Secondary outcomes (4)
Pain as measured by the nonverbal rating scale
Measured: 0-2h after begin of fentanyl infusion at 15 min intervals
cold pressor pain
Measured: at -15min, 1h, 2h, 3h, 4h, 5h, 6h, 6h30min after begin of infusion
Lab values (B-endorphin, fentanyl plasma Levels, potentially Adrenocorticotropic hormone (ACTH) / cortisol)
Measured: -15min, -10min, -5 min, 0 min, 15 min, 30 min, 45min, 1h, 1h 30min, 2h, 4h 30min, 4h 35min, 4h 40min, 4h 45min, 5h, 5h 30min, 6h, 6h 30min after begin of infusion
pupillary dilation response
Measured: baseline and at 4.5h after begin of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionJan 2015
- Study completionJan 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 HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wilhelm Ruppen, PD Dr., MD, Principal investigator, University Hospital Basel, Dep. of Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252458
- Sponsor's protocol ID
- 2014-054
- Acronym
- FentaOIH-V
- Status last verified
- Jan 2015
- First submitted
- 8 Sep 2014
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mauermann E, Blum CA, Lurati Buse G, Bandschapp O, Ruppen W. Time course of copeptin during a model of experimental pain and hyperalgesia: A randomised volunteer crossover trial. Eur J Anaesthesiol. 2017 May;34(5):306-314. doi: 10.1097/EJA.0000000000000592.
PubMed 28106611
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Fentanyl Lead to Opioid-induced Hyperalgesia in Healthy Volunteers? A Prospective, Randomized, Double-blinded Crossover Study
- ClinicalTrials.gov ID
- NCT02252458
- Acronym / sponsor ID
- FentaOIH-V / 2014-054
- Conditions
- Healthy
- Keywords
- Opioid induced hyperalgesia, Fentanyl
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 30 Sep 2014 (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.
The purpose of this study is to examine whether two clinically sensible dose regimen of fentanyl (low dose vs. high dose) lead to different pain scores as measured by the nonverbal rating scale (NRS) in healthy volunteers at 4.5 to 6.5 hours after fentanyl application. Pain modalities tested will include transdermal electrical stimulation and cold pressor pain.
The investigators hypothesize that the high dose fentanyl group will have an increase of approximately 20% in the NRS.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl high dose | Experimental | Drug: FentanylFentanyl 10mcg/kg of bodyweight |
| Fentanyl low dose | Active comparator | Drug: FentanylFentanyl 1mcg/kg of bodyweight |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy (ASA I-II) male volunteers
- Age > 18 years
- BMI 18 - 25 kg/m2
Key exclusion criteria (11 listed)
- Volunteers unable to give written informed consent
- Known drug allergies or intolerance to fentanyl
- Known drug allergies or intolerance to morphine and other opiates
- Recreational drug addiction or abuse
- Opiate use in the last month
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 |
|---|---|---|
| Fentanyl | Drug | Fentanyl high dose, Fentanyl low dose |
Primary outcome
COMPOSITE of pain scores as measured by the nonverbal rating scale (NRS) at 15 minute intervals within the timeframe specified below.
Time frame: 4.5 to 6.5h after begin of fentanyl infusion
4 secondary outcomes
Pain as measured by the nonverbal rating scale
Time frame: 0-2h after begin of fentanyl infusion at 15 min intervals
cold pressor pain
Time frame: at -15min, 1h, 2h, 3h, 4h, 5h, 6h, 6h30min after begin of infusion
Lab values (B-endorphin, fentanyl plasma Levels, potentially Adrenocorticotropic hormone (ACTH) / cortisol)
Time frame: -15min, -10min, -5 min, 0 min, 15 min, 30 min, 45min, 1h, 1h 30min, 2h, 4h 30min, 4h 35min, 4h 40min, 4h 45min, 5h, 5h 30min, 6h, 6h 30min after begin of infusion
pupillary dilation response
Time frame: baseline and at 4.5h after begin of infusion
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 9 Jan 2015.
- Derived from this study: PubMed 28106611Mauermann E, Blum CA, Lurati Buse G, Bandschapp O, Ruppen W. Time course of copeptin during a model of experimental pain and hyperalgesia: A randomised volunteer crossover trial. Eur J Anaesthesiol. 2017 May;34(5):306-314. doi: 10.1097/EJA.0000000000000592.
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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.
Wilhelm Ruppen, PD Dr., MD principal investigator
University Hospital Basel, Dep. of Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl in people with Healthy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 3 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 9 Jan 2015. 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 Switzerland. 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?
COMPOSITE of pain scores as measured by the nonverbal rating scale (NRS) at 15 minute intervals within the timeframe specified below. (time frame: 4.5 to 6.5h after begin of fentanyl infusion). 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 NCT02252458, 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 9 Jan 2015.