Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine (PASORII)
This study has been completed.
Sponsor:
mads u werner
Collaborator:
Norpharma A/S
Information provided by (Responsible Party):
mads u werner, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01296334
First received: February 14, 2011
Last updated: February 4, 2013
Last verified: February 2013
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Purpose
Tissue injury is associated with pain from the injured site (primary hyperalgesia) and pain from non-injured tissue in the vicinity of the trauma (secondary hyperalgesia). In the present study we investigate primary and secondary hyperalgesia in healthy volunteers following an experimental first degree burn injury.
The objectives are:
- to compare analgesic and anti-hyperalgesic effects of two opioids (morphine and buprenorphine).
- to investigate if these effects are related to the volunteers individual pain sensitivity
| Condition | Intervention |
|---|---|
|
Pain |
Drug: morphine Drug: Morphine Drug: Buprenorphine Other: saline |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine Following an Experimental Inflammatory Injury in Volunteers. |
Resource links provided by NLM:
Further study details as provided by University of Copenhagen:
Primary Outcome Measures:
- Analgesic and antihyperalgesic effects [ Time Frame: 0 min after a first degree burn injury ] [ Designated as safety issue: No ]Analgesic effect is assessed by change in primary hyperalgesia (pain rating [VAS]) Antihyperalgesic effect is assessed by reduction in area of hyperalgesia (sq. cm) VAS-area under curve is calculated for 0, 60, 120 and 180 min after first degree burn injury
- Analgesic and antihyperalgesic effects [ Time Frame: 60 min after first degree burn injury ] [ Designated as safety issue: No ]Analgesic effect is assessed by change in primary hyperalgesia (pain rating [VAS]) Antihyperalgesic effect is assessed by reduction in area of hyperalgesia (sq. cm) VAS-area under curve is calculated for 0, 60, 120 and 180 min after first degree burn injury.
- Analgesic and antihyperalgesic effects [ Time Frame: 120 min after first degree burn injury ] [ Designated as safety issue: No ]Analgesic effect is assessed by change in primary hyperalgesia (pain rating [VAS]) Antihyperalgesic effect is assessed by reduction in area of hyperalgesia (sq. cm) VAS-area under curve is calculated for 0, 60, 120 and 180 min after first degree burn injury
- Analgesic and antihyperalgesic effects [ Time Frame: 180 min after first degree burn injury ] [ Designated as safety issue: No ]Analgesic effect is assessed by change in primary hyperalgesia (pain rating [VAS]) Antihyperalgesic effect is assessed by reduction in area of hyperalgesia (sq. cm) VAS-area under curve is calculated for 0, 60, 120 and 180 min after first degree burn injury
Secondary Outcome Measures:
- Difference in analgesic/antihyperalgesic profile between pain-sensitive and pain-non-sensitive individuals [ Time Frame: 0-180 min after first degree burn injury ] [ Designated as safety issue: No ]The ratios between areas under curve (0-180 min after first degree burn injury) for analgesic effect assessed by change in primary hyperalgesia (pain rating VAS])and antihyperalgesic effect assessed by reduction in area of hyperalgesia (sq. cm).
| Enrollment: | 34 |
| Study Start Date: | February 2011 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: morphine low dose |
Drug: morphine
intravenous infusion, 10 mg, once, 4 hours
|
| Experimental: morphine high dose |
Drug: Morphine
intravenous infusion, 20 mg, once, 4 hours
|
| Experimental: buprenorphine low dose |
Drug: Buprenorphine
intravenous infusion, 0.3 mg, once, 4 hours
|
| Experimental: buprenorphine high dose |
Drug: Buprenorphine
intravenous infusion, 0.6 mg, once, 4 hours
|
| Placebo Comparator: placebo |
Other: saline
intravenous infusion, 0.9% saline, once, 4 hours
|
Eligibility| Ages Eligible for Study: | 20 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- healthy individuals
- adequate psychomotor performance to perform pain tests
- pain-sensitive or pain-nonsensitive according to prespecified criteria
Exclusion Criteria:
- known allergy to morphine or buprenorphine
- prior adverse experiences with opioids
- history of abuse
- females not taking P-pills
- skin lesions on the test-sites
- suffering from chronic pain
- medication with analgesics
- BMI > 28
- smoker
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296334
Locations
| Denmark | |
| Zelo Phase One Clinical Trial Unit, Bispebjerg Hospital | |
| Copenhagen NV, Denmark, 2400 | |
Sponsors and Collaborators
mads u werner
Norpharma A/S
Investigators
| Study Director: | Mads U Werner, MD, DMSc | Multidisciplinary Pain Centre 7612, Rigshospitalet, Blegdamsvej 9, DK 2100 Copenhagen O |
| Study Chair: | Lona L Christrup, MSc , PhD | Pharmaceutical Faculty, Copenhagen University |
More Information
Publications:
| Responsible Party: | mads u werner, MD, University of Copenhagen |
| ClinicalTrials.gov Identifier: | NCT01296334 History of Changes |
| Other Study ID Numbers: | H-2-2010-115, 2010-022903-23 |
| Study First Received: | February 14, 2011 |
| Last Updated: | February 4, 2013 |
| Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics Denmark: Danish Medicines Agency |
Keywords provided by University of Copenhagen:
|
opioids analgesia secondary hyperalgesia quantitative sensory testing inflammatory injury |
Additional relevant MeSH terms:
|
Analgesics Buprenorphine Morphine Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Analgesics, Opioid Central Nervous System Depressants Narcotic Antagonists Narcotics |
ClinicalTrials.gov processed this record on June 17, 2013