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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022903-23 | EudraCT Number |
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| Name | Class |
|---|---|
| Norpharma A/S | INDUSTRY |
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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:
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].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| morphine low dose | Experimental | morphine infusion 10 mg over a 210 min period |
|
| morphine high dose | Experimental | morphine infusion 20 mg over a 210 min period |
|
| buprenorphine low dose | Experimental | buprenorphine infusion 0.3 mg over a 210 min period |
|
| buprenorphine high dose | Experimental | buprenorphine infusion 0.6 mg over a 210 min period |
|
| placebo | Placebo Comparator | placebo (normal saline) infusion 0.6 mg over a 210 min period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| morphine LO | Drug | intravenous infusion, 10 mg, once, 4 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mads U Werner, MD, DMSc | Multidisciplinary Pain Centre 7612, Rigshospitalet, Blegdamsvej 9, DK 2100 Copenhagen O | Study Director |
| Lona L Christrup, MSc, PhD | Pharmaceutical Faculty, Copenhagen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zelo Phase One Clinical Trial Unit, Bispebjerg Hospital | Copenhagen NV | 2400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16154698 | Background | 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. | |
| 23359655 | Result | 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. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| D006930 | Hyperalgesia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Morphine Hi | Drug | intravenous infusion, 20 mg, once, 4 hours |
|
|
| Buprenorphine LO | Drug | intravenous infusion, 0.3 mg, once, 4 hours |
|
|
| Buprenorphine Hi | Drug | intravenous infusion, 0.6 mg, once, 4 hours |
|
|
| saline | Other | intravenous infusion, 0.9% saline, once, 4 hours |
|
|
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |