Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine

Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine Following an Experimental Inflammatory Injury in Volunteers.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01296334

Acronym

PASORII

Enrollment

Registered

2011-02-15

Start date

2011-02-28

Completion date

2011-10-31

Last updated

2016-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

opioids, analgesia, secondary hyperalgesia, quantitative sensory testing, inflammatory injury

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 \[pii\].

Interventions

DRUGmorphine LO

intravenous infusion, 10 mg, once, 4 hours

DRUGMorphine Hi

intravenous infusion, 20 mg, once, 4 hours

DRUGBuprenorphine LO

intravenous infusion, 0.3 mg, once, 4 hours

DRUGBuprenorphine Hi

intravenous infusion, 0.6 mg, once, 4 hours

OTHERsaline

intravenous infusion, 0.9% saline, once, 4 hours

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026