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Completed

NCT Number: NCT01296334

Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine

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

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Key information

Conditions

Pain Agnosia Hyperalgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zelo Phase One Clinical Trial Unit, Bispebjerg Hospital

Copenhagen NV, 2400, Denmark

About this study

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].

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

morphine LO

Drug

intravenous infusion, 10 mg, once, 4 hours

Other names: Morfin SAD

Morphine Hi

Drug

intravenous infusion, 20 mg, once, 4 hours

Other names: Morfin SAD

Buprenorphine LO

Drug

intravenous infusion, 0.3 mg, once, 4 hours

Other names: Temgesic

Buprenorphine Hi

Drug

intravenous infusion, 0.6 mg, once, 4 hours

Other names: Temgesic

Saline

Other

intravenous infusion, 0.9% saline, once, 4 hours

Other names: 0.9% NaCl

Primary outcomes

  1. Analgesic and antihyperalgesic effects

    Time frame: 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 outcomes

  1. Difference in analgesic/antihyperalgesic profile between pain-sensitive and pain-non-sensitive individuals

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

mads u werner

Other

Collaborators

  • Norpharma A/S

Registry information

Official study title

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

Acronym: PASORII

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 15, 2011
Registry last updated
Nov 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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