Effect of High Dose Naloxone on Secondary Hyperalgesia

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01935206
• Other study ID #: H-2-2012-174
• Status: Completed
• Phase: Phase 1
• First received: August 19, 2013
• Last updated: February 24, 2014
• Start date: June 2013
• Est. completion date: November 2013

Study information

• Verified date: February 2014
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: regional Research Ethical CommitteeDenmark: Data Protection AgencyDenmark: Danish Medicines AgencyDenmark: Good Clinical Practice unit - University Hospitals Copenhagen
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hyperalgesia
• Naloxone
• Opioid Antagonist
• Pain

Intervention

Drug:
• Naloxone (2 mg/kg)

• Placebo

Locations

Country	Name	City	State
Denmark	Dept Anaesthesiology HOC, 4231, Rigshospitalet	Copenhagen
Denmark	Multidisciplinary Pain Center	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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