Analgesia, Antihyperalgesia
Conditions
Brief summary
A study investigating the analgesic effect of melatonin in a human heat injury model using quantitative sensory testing.
Interventions
Sponsors
University of Copenhagen
Lars Peter Holst Andersen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males aged between 20 and 40 years
Exclusion criteria
* Under aged/minors * Does not speak or understand danish * Alcohol or abuse of medicines * Prior QST-trial within the last 2 month * Prior medical trail within the last month * Serious comorbidity (ASA-class 3-4) * Chronic pain (defined by analgesic treatment) Shift-work or night work within the last 14 days Known sleep-disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain (VAS) | During burn injury. 1 hours following melatonin/placebo administration | — |
| Change in areas of secondary hyperalgesia | 1,2,4,6 hours following burn injury, which corresponds to 2,3,5 and 7 hours after melatonin/placebo-administration | Areas of secondary hyperalgesia will be assessed by quantitative sensory testing |
Secondary
| Measure | Time frame |
|---|---|
| Change in erythema/oedema assessed by ultrasound | 1,2,4,6 hours following burn injury, which corresponds to 2,3,5 and 7 hours after melatonin/placebo-administration |
| Thermal thresholds assessed by quantitative sensory testing | 1,2,4,6 hours following burn injury, which corresponds to 2,3,5 and 7 hours after melatonin/placebo-administration |
| Mechanical thresholds assessed quantitative sensory testing | 1,2,4,6 hours following burn injury, which corresponds to 2,3,5 and 7 hours after melatonin/placebo-administration |
Countries
Denmark
Outcome results
None listed