Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine

mads u werner34 enrolled

Overview

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

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 \[pii\].

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Pain

Interventions

morphine LODRUG

intravenous infusion, 10 mg, once, 4 hours

Morphine HiDRUG

intravenous infusion, 20 mg, once, 4 hours

Buprenorphine LODRUG

intravenous infusion, 0.3 mg, once, 4 hours

Buprenorphine Hi

Eligibility

Sex: ALLMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Zelo Phase One Clinical Trial Unit, Bispebjerg Hospital

Copenhagen NV, Denmark

Outcomes

Primary Outcomes

Analgesic and antihyperalgesic effects

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

Time frame: 0 to 180 min after a first degree burn injury

Secondary Outcomes

Difference in analgesic/antihyperalgesic profile between pain-sensitive and pain-non-sensitive individuals

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).

Time frame: 0-180 min after first degree burn injury

Data from ClinicalTrials.gov

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