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Recent studies have focused on the role of endogenous opioids on central sensitization. Central sensitization is known to be impaired or altered in chronic pain conditions, as fibromyalgia or chronic tension headache.
Animal studies have shown reinstatement of mechanical hypersensitivity following naloxone administration after resolution of an injury. This suggests latent sensitization.
In the present study, investigators hypothesize that naloxone (2 mg/kg) can reinstate secondary hyperalgesia 168 hours after a first-degree burn-injury. Investigators aim therefore to show that latent sensitization is present in humans and is modulated by endogenous opioids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | The effect of naloxone (2 mg/kg) on secondary hyperalgesia 168 hours after a first-degree burn-injury is compared to the placebo effect. |
|
| Naloxone (2 mg/kg) | Experimental | The effect of naloxone (2 mg/kg) on secondary hyperalgesia 168 hours after a first-degree burn-injury is compared to the placebo effect. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naloxone (2 mg/kg) | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Secondary hyperalgesia area (cm2) surrounding a first-degree burn injury before and after infusion of naloxone/placebo | Areas of secondary hyperalgesia surrounding a first degree burn-injury will be assessed before and after infusion of naloxone/placebo. | 1h, 2h, 3h, 168h, 168h15min, 168h30min post-burn |
| Measure | Description | Time Frame |
|---|---|---|
| Change in allodynic area (cm2) surrounding a first-degree burn injury before and after infusion of naloxone/placebo | Areas of allodynia surrounding a first degree burn-injury will be assessed before and after infusion of naloxone/placebo. | 1h, 2h, 3h, 168h, 168h15min, 168h30min post-burn |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mechanical Pain Thresholds at primary hyperalgesia site before and after naloxone/placebo infusion | Mechanical Pain Thresholds will be assessed with pinprick stimulators at baseline and after infusion of naloxone/placebo at the primary hyperalgesia site (following a first degree burn) and in the contralateral leg. | 0h, 168h, 168h30min |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joergen B Dahl, M.D., DMSc | Dept Anaesthesiology, HOC, 4231, Rigshospitalet | Study Director |
| Mads U. Werner, M.D., Ph.D., DMSc | Multidisciplinary Pain Center, 7612, Rigshospitalet, Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept Anaesthesiology HOC, 4231, Rigshospitalet | Copenhagen | Copenhagen | 2100 | Denmark | ||
| Multidisciplinary Pain Center |
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| ID | Term |
|---|---|
| D006930 | Hyperalgesia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D009270 | Naloxone |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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|
| Copenhagen |
| Copenhagen |
| 2100 |
| Denmark |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |