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Effect of High Dose Naloxone on Secondary Hyperalgesia

Primary Purpose

Hyperalgesia, Pain, Naloxone

Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Naloxone (2 mg/kg)
Placebo
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hyperalgesia focused on measuring secondary hyperalgesia, allodynia, mechanical pain threshold, naloxone, endogenous opioids, pain

Eligibility Criteria

20 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Dept Anaesthesiology HOC, 4231, Rigshospitalet
  • Multidisciplinary Pain Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Naloxone (2 mg/kg)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 19, 2013
Last Updated
February 24, 2014
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01935206
Brief Title
Effect of High Dose Naloxone on Secondary Hyperalgesia
Official Title
Effect of a High-dose Naloxone Infusion on Secondary Hyperalgesia After a First-degree Burn
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperalgesia, Pain, Naloxone, Opioid Antagonist
Keywords
secondary hyperalgesia, allodynia, mechanical pain threshold, naloxone, endogenous opioids, pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The effect of naloxone (2 mg/kg) on secondary hyperalgesia 168 hours after a first-degree burn-injury is compared to the placebo effect.
Arm Title
Naloxone (2 mg/kg)
Arm Type
Experimental
Arm Description
The effect of naloxone (2 mg/kg) on secondary hyperalgesia 168 hours after a first-degree burn-injury is compared to the placebo effect.
Intervention Type
Drug
Intervention Name(s)
Naloxone (2 mg/kg)
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in Secondary hyperalgesia area (cm2) surrounding a first-degree burn injury before and after infusion of naloxone/placebo
Description
Areas of secondary hyperalgesia surrounding a first degree burn-injury will be assessed before and after infusion of naloxone/placebo.
Time Frame
1h, 2h, 3h, 168h, 168h15min, 168h30min post-burn
Secondary Outcome Measure Information:
Title
Change in allodynic area (cm2) surrounding a first-degree burn injury before and after infusion of naloxone/placebo
Description
Areas of allodynia surrounding a first degree burn-injury will be assessed before and after infusion of naloxone/placebo.
Time Frame
1h, 2h, 3h, 168h, 168h15min, 168h30min post-burn
Other Pre-specified Outcome Measures:
Title
Change in Mechanical Pain Thresholds at primary hyperalgesia site before and after naloxone/placebo infusion
Description
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.
Time Frame
0h, 168h, 168h30min

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joergen B Dahl, M.D., DMSc
Organizational Affiliation
Dept Anaesthesiology, HOC, 4231, Rigshospitalet
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mads U. Werner, M.D., Ph.D., DMSc
Organizational Affiliation
Multidisciplinary Pain Center, 7612, Rigshospitalet, Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept Anaesthesiology HOC, 4231, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Multidisciplinary Pain Center
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

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Effect of High Dose Naloxone on Secondary Hyperalgesia

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