Clinical trial NCT01296334: Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine
Official title: Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine Following an Experimental Inflammatory Injury in Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: opioids
analgesia
secondary hyperalgesia
quantitative sensory testing
inflammatory injury
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Norpharma A/S
First posted: 2011-02-15
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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 \[pii\].

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
* smoker

Primary outcomes:
measure: Analgesic and antihyperalgesic effects
timeFrame: 0 to 180 min after a first degree burn injury
Secondary outcomes:
measure: Difference in analgesic/antihyperalgesic profile between pain-sensitive and pain-non-sensitive individuals
timeFrame: 0-180 min after first degree burn injury
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Zelo Phase One Clinical Trial Unit, Bispebjerg Hospital
Study officials:
affiliation: Multidisciplinary Pain Centre 7612, Rigshospitalet, Blegdamsvej 9, DK 2100 Copenhagen O
name: Mads U Werner, MD, DMSc
role: STUDY_DIRECTOR
affiliation: Pharmaceutical Faculty, Copenhagen University
name: Lona L Christrup, MSc, PhD
role: STUDY_CHAIR
References:
citation: Koppert W, Ihmsen H, Korber N, Wehrfritz A, Sittl R, Schmelz M, Schuttler J. Different profiles of buprenorphine-induced analgesia and antihyperalgesia in a human pain model. Pain. 2005 Nov;118(1-2):15-22. doi: 10.1016/j.pain.2005.06.030. Epub 2005 Sep 9.
citation: Ravn P, Secher EL, Skram U, Therkildsen T, Christrup LL, Werner MU. 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. 2013;6:23-38. doi: 10.2147/JPR.S36827. Epub 2013 Jan 9.