The effect of late infusion of Naloxon, a drug that neutralizes the effect of morphine, on pain sensitivity after a first degree burn injury

Conditions: Induced pain in volunteers
MedDRA version: 14.1Level: PTClassification code 10033371Term: PainSystem Organ Class: 10018065 - General disorders and administration site conditions
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2012-000839-54-DK

Lead Sponsor: Rigshospitalet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Healthy
Age betwen 20 and 35
Volunteers that have given there written concent to participate in the clinical trial and understand the trial.
Urinary test with no trace of opioids
Negative pregnancy test
ASA 1-2
Body mass index (BMI): 18 < BMI < 30

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Volunteers that can not cooperate
Volunteers that do not understand and read danish
Women who are planning to be pregnant, are pregnant or are breastfeeding
Women how do not use birthcontrol
Have been in another clinical trial the last 60 days
Any form of injury or any other influence of the nerves on the calf
Any neurological disease
use of any psychoactive drugs
Abuse of alcohol or drug
Chronical pain
regular use of analgesia (more than twice a week)
Know allergy to morphine or other morphine drug incl. Naloxon
Skin lesion on the calf
Has taken medicin prescription a week before the trial
Has taken over the counter medicin 48 hours before the trial
Psychological instabel - investigators evaluation

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 73 hours after induced burn injury;Main Objective: The main objective is to investigate if the administration of naloxon can reinduce secundary hyperalgesia areas after a first degree burn injury in volunteers ;Secondary Objective: None;Primary end point(s): Primary end point is the areas of the secondary hyperalgesia<br><br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): WDT - Warm - Detection Threshold<br>HPT - Heat Pain Threshold<br>MPT - Mecanic Pain Threshold<br>HADS - Hospital Anxiety and Depression Scale<br>;Timepoint(s) of evaluation of this end point: 3 hours after incuced burn injury