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NCT Number: NCT01935206

Effect of High Dose Naloxone on Secondary Hyperalgesia

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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Key information

Conditions

Hyperalgesia Naloxone Nervous System Diseases Neurologic Manifestations Opioid Antagonist Pain Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

20 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Dept Anaesthesiology HOC, 4231, Rigshospitalet, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naloxone (2 mg/kg)

Drug

Placebo

Drug

Primary outcomes

  1. 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 outcomes

  1. 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.

Other outcomes

  1. Change in Mechanical Pain Thresholds at primary hyperalgesia site before and after naloxone/placebo infusion

    Time frame: 0h, 168h, 168h30min

    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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 5, 2013
Registry last updated
Feb 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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