First degree burn injury in healthy volunteers MedDRA version: 14.1 Level: LLT Classification code 10020573 Term: Hyperalgesia System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Naloxone
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: NALOXONE
CAS Number: 465-65-6
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Sponsors
HOC, Rigshospitalet
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: male, healthy, age between 20 and 35, BMI between 18 and 30, verbal and written informed consent, normal cardiac ultrasound examination, normal ECG 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 49 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: unable to cooperate, not able to understand Danish or English, neurological disease, psychiatric disease, drug or alcohol abuse, chronic pain state, positive urine test for opioids (morphine, methadone, buprenorphine), skin infection in the test areas (lower leg), allergy to morphine-related drugs, chronic pain medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to evaluate if naloxone can re-instate secondary hyperalgesia areas 7 days after a burn injury;Secondary Objective: The secondary objective is to examine if naloxone can re-instate hyperalgesia, evaluated by thermal (warmth detection thresholds, heat pain thresholds) and mechanical (pin-prick thresholds) after a first degree burn injury. Psychometrics (Hospital Anxiety and Depression Scale [HADS], Pain Catastrophizing Scale [PCS]) and correlation with pain-related variables.;Primary end point(s): Primary outcome is areas of secondary hyperalgesia;Timepoint(s) of evaluation of this end point: Secondary hyperalgesia areas are evaluated before and 1,2,3,165,168 + 168½ hrs after the burn injury. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Thermal and mechanical thresholds, and, psychometrics;Timepoint(s) of evaluation of this end point: Thermal thresholds are assessed at baseline and 1,2,3 hours after the burn injury. Mechanical thresholds are assessed at baseline and 1,2,3,165,168 + 168½ hrs after the burn injury. Psychometrics are obtained at baseline. | — |
Countries
Denmark
Contacts
Public ContactDept. Anaesthesiology 4231, HOC
HOC, Rigshospitalet
Outcome results
None listed