Pain Clinical Trial
Official title:
Effect of a High-dose Naloxone Infusion on Secondary Hyperalgesia After a First-degree Burn
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 35 Years |
Eligibility |
Inclusion Criteria: - healthy man - written informed consent - ASA 1-2 - BMI 18 < BMI < 30 - normal ultrasound examination of the heart - normal ECG - urin sample without traces of opioids Exclusion Criteria: - volunteers, who do not understand the Danish language - participation in another experimental trial in the previous 60 days - nerve damage or skin lesions in the assessment areas - neurological or psychiatric condition - use of psycho-active drugs - abuse of alcohol or drugs - chronic pain - regular use of pain-killers (> 1 a week) - allergy against morphine or other opioids (including naloxone) - use of prescription drugs 1 week prior to the trial - use of over-the-counter medication 48 hours prior to the trial - urin sample with traces of opioids - volunteer is not suitable for the trial according to the investigator's consideration |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Denmark | Dept Anaesthesiology HOC, 4231, Rigshospitalet | Copenhagen | |
Denmark | Multidisciplinary Pain Center | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | No |
Primary | 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 | No |
Secondary | 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 | No |
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