Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine

Not Applicable

Completed

• Conditions: Pain
• Interventions: Other: saline; Drug: morphine LO; Drug: Morphine Hi; Drug: Buprenorphine LO; Drug: Buprenorphine Hi

• Registration Number: NCT01296334
• Lead Sponsor: mads u werner

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 \[pii\].

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-14
• Study First Submitted QC: 2011-02-14
• Study First Posted: 2011-02-15
• Primary Completion: 2011-09
• Study Completion: 2011-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-23
• Last Update Posted: 2016-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo	saline	placebo (normal saline) infusion 0.6 mg over a 210 min period
morphine low dose	morphine LO	morphine infusion 10 mg over a 210 min period
morphine high dose	Morphine Hi	morphine infusion 20 mg over a 210 min period
buprenorphine low dose	Buprenorphine LO	buprenorphine infusion 0.3 mg over a 210 min period
buprenorphine high dose	Buprenorphine Hi	buprenorphine infusion 0.6 mg over a 210 min period

Primary Outcome Measures

Name	Time	Method
Analgesic and antihyperalgesic effects	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 Outcome Measures

Name	Time	Method
Difference in analgesic/antihyperalgesic profile between pain-sensitive and pain-non-sensitive individuals	0-180 min after first degree burn injury	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).

Trial Locations

Locations (1)

Zelo Phase One Clinical Trial Unit, Bispebjerg Hospital; 🇩🇰 Copenhagen NV, Denmark