Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine

Pain Clinical Trial

— PASORII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01296334
• Other study ID #: H-2-2010-115
• Secondary ID: 2010-022903-23
• Status: Completed
• Phase: N/A
• First received: February 14, 2011
• Last updated: November 23, 2016
• Start date: February 2011
• Est. completion date: October 2011

Study information

• Verified date: November 2016
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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

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].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• morphine LO
intravenous infusion, 10 mg, once, 4 hours
• Morphine Hi
intravenous infusion, 20 mg, once, 4 hours
• Buprenorphine LO
intravenous infusion, 0.3 mg, once, 4 hours
• Buprenorphine Hi
intravenous infusion, 0.6 mg, once, 4 hours

Other:
• saline
intravenous infusion, 0.9% saline, once, 4 hours

Locations

Country	Name	City	State
Denmark	Zelo Phase One Clinical Trial Unit, Bispebjerg Hospital	Copenhagen NV

Sponsors (2)

Lead Sponsor	Collaborator
mads u werner	Norpharma A/S

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Koppert W, Ihmsen H, Körber N, Wehrfritz A, Sittl R, Schmelz M, Schüttler J. Different profiles of buprenorphine-induced analgesia and antihyperalgesia in a human pain model. Pain. 2005 Nov;118(1-2):15-22. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	0 to 180 min after a first degree burn injury	No
Secondary	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).	0-180 min after first degree burn injury	No