Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine Following an Experimental Inflammatory Injury in Volunteers.
Overview
- Phase
- Not Applicable
- Intervention
- morphine LO
- Conditions
- Pain
- Sponsor
- mads u werner
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Analgesic and antihyperalgesic effects
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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
Detailed Description
Please refer to: Ravn P, Secher EL, Skram U, Therkildsen T, Christrup LL, Werner MU (2013) Morphine- and buprenorphine-induced analgesia and antihyperalgesia in a human inflammatory pain model: a double-blind, randomized, placebo-controlled, five-arm crossover study. J Pain Res 6: 23-38. 10.2147/JPR.S36827 \[doi\];jpr-6-023 \[pii\].
Investigators
mads u werner
MD
University of Copenhagen
Eligibility 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
Arms & Interventions
morphine low dose
morphine infusion 10 mg over a 210 min period
Intervention: morphine LO
morphine high dose
morphine infusion 20 mg over a 210 min period
Intervention: Morphine Hi
buprenorphine low dose
buprenorphine infusion 0.3 mg over a 210 min period
Intervention: Buprenorphine LO
buprenorphine high dose
buprenorphine infusion 0.6 mg over a 210 min period
Intervention: Buprenorphine Hi
placebo
placebo (normal saline) infusion 0.6 mg over a 210 min period
Intervention: saline
Outcomes
Primary Outcomes
Analgesic and antihyperalgesic effects
Time Frame: 0 to 180 min after a first degree burn injury
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 Outcomes
- Difference in analgesic/antihyperalgesic profile between pain-sensitive and pain-non-sensitive individuals(0-180 min after first degree burn injury)