Effect of High Dose Naloxone on Secondary Hyperalgesia

Overview

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.

Full Title of Study: “Effect of a High-dose Naloxone Infusion on Secondary Hyperalgesia After a First-degree Burn”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 2013

Interventions

  • Drug: Naloxone (2 mg/kg)
  • Drug: Placebo

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • The effect of naloxone (2 mg/kg) on secondary hyperalgesia 168 hours after a first-degree burn-injury is compared to the placebo effect.
  • Experimental: Naloxone (2 mg/kg)
    • The effect of naloxone (2 mg/kg) on secondary hyperalgesia 168 hours after a first-degree burn-injury is compared to the placebo effect.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Secondary hyperalgesia area (cm2) surrounding a first-degree burn injury before and after infusion of naloxone/placebo
    • Time Frame: 1h, 2h, 3h, 168h, 168h15min, 168h30min post-burn
    • Areas of secondary hyperalgesia surrounding a first degree burn-injury will be assessed before and after infusion of naloxone/placebo.

Secondary Measures

  • Change in allodynic area (cm2) surrounding a first-degree burn injury before and after infusion of naloxone/placebo
    • Time Frame: 1h, 2h, 3h, 168h, 168h15min, 168h30min post-burn
    • Areas of allodynia surrounding a first degree burn-injury will be assessed before and after infusion of naloxone/placebo.

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 20 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rigshospitalet, Denmark
  • Provider of Information About this Clinical Study
    • Principal Investigator: Manuel Pereira, M.D. – Rigshospitalet, Denmark
  • Overall Official(s)
    • Joergen B Dahl, M.D., DMSc, Study Director, Dept Anaesthesiology, HOC, 4231, Rigshospitalet
    • Mads U. Werner, M.D., Ph.D., DMSc, Principal Investigator, Multidisciplinary Pain Center, 7612, Rigshospitalet, Copenhagen

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