Clinical trial NCT01015482: The Effect of High-dose Remifentanil on Established Sunburn-induced Hyperalgesia in Human Volunteers (HighDose RemiSun)
Official title: The Effect of High-dose Remifentanil on Established Sunburn-induced Hyperalgesia in Human Volunteers (HighDose RemiSun)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hyperalgesia
Keywords: Sunburn
Remifentanil
Hyperalgesia
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-11-18
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Treatment of chronic pain is a major clinical challenge since chronic pain is frequent and leads to deterioration of quality of life. An injury or wound can lead to long term changes in the nervous system that make the skin more sensitive at and near the injury; this is termed hyperalgesia and occurs through long term depotentiation (LTP), i.e., a change in the synaptic interaction between neurons.

Opioids are the gold standard for the symptomatic therapy of moderate to severe pain. Now, in animal studies the investigators have discovered previously unrecognized effects of opioids.

UV-B irradaition of the skin of the thigh is an established model of priamary and secondary hyperalgeisa in humans. The investigators want to test the influence of remifentanil, an ultra-short acting opioid, on hyperalgesia observed after UV-B irradiation in human volunteers in a double blind cross-over prospective active placebo controlled clinical trial, at a dose corresponding to 0.7 µg kg-1 min-1.


Eligibility criteria: Inclusion Criteria:

* Body mass index between 15th and 85th percentile
* Normal findings in the medical history and physical examination
* Drug free for 1 week prior to the study day

Exclusion Criteria:

* Regular use of medication especially analgesics
* Abuse of alcoholic beverages, drug abuse
* History of asthma
* Participation in a clinical trial in the 2 weeks preceding the study
* Symptoms of a clinically relevant illness in the 2 weeks before the first study day
* Resting systolic blood pressure \> 135 mmHg or diastolic blood pressure \> 85 mmHg
* Acute skin diseases like sunburn on the relevant areas or skin lesions
* Pregnancy or breast feeding
* UV sensitive skin conditions, like Xeroderma pigmentosa

Primary outcomes:
measure: Measure: Area of pin prick hyperalgesia
timeFrame: 0-6h
Secondary outcomes:
measure: Stimulus-response (SR) function to a set of modified rigid von Frey filaments (8-512 mN)
timeFrame: 0-6h
measure: Heat pain threshold within the area of mechanical hyperalgesia
timeFrame: 0-6h
measure: Mechanical pain threshold within the area of pin prick hyperalgesia, area of dynamic allodynia to brush
timeFrame: 0-6h
measure: Adverse effects
timeFrame: 30 and 59 min after start of treatment
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Anaesthesia, Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Astrid Chiari, MD
role: PRINCIPAL_INVESTIGATOR
References: