NCT01935206

Effect of High Dose Naloxone on Secondary Hyperalgesia

Effect of a High-dose Naloxone Infusion on Secondary Hyperalgesia After a First-degree Burn

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: Male
• Age: 20 Years – 35 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Hyperalgesia
• Pain
• Naloxone
• Opioid Antagonist

Interventions

Type	Name	Description
DRUG	Naloxone (2 mg/kg)
DRUG	Placebo

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2013-09-05
• Last updated: 2014-02-25

Locations

2 sites across 1 country: Denmark