Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine (PASORII)

mads u werner

Status: Completed

Conditions: Pain

Treatments: Other: saline; Drug: Buprenorphine Hi; Drug: Morphine Hi; Drug: Buprenorphine LO; Drug: morphine LO

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01296334

2010-022903-23 (EudraCT Number)

H-2-2010-115

Details and patient eligibility

About

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

Full 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].

Enrollment: 34 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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34 participants in 5 patient groups, including a placebo group

morphine low dose

Experimental group

Description:

morphine infusion 10 mg over a 210 min period

Treatment:

Drug: morphine LO

morphine high dose

Experimental group

Description:

morphine infusion 20 mg over a 210 min period

Treatment:

Drug: Morphine Hi

buprenorphine low dose

Experimental group

Description:

buprenorphine infusion 0.3 mg over a 210 min period

Treatment:

Drug: Buprenorphine LO

buprenorphine high dose

Experimental group

Description:

buprenorphine infusion 0.6 mg over a 210 min period

Treatment:

Drug: Buprenorphine Hi

placebo

Placebo Comparator group

Description:

placebo (normal saline) infusion 0.6 mg over a 210 min period

Treatment:

Other: saline