drugset / Trial / NCT01015482

The Effect of High-dose Remifentanil on Established Sunburn-induced Hyperalgesia in Human Volunteers (HighDose RemiSun)

NCT01015482

Phase 4 Unknown 24 enrolled Medical University of Vienna
RandomizedCrossoverDouble-blindBasic science

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.

Timeline

Start
2009-11
Primary completion
2010-03
Completion
2010-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Midazolam Small molecule
Subject Remifentanil Small molecule 0.7 ug/kg

Indications

No indication recorded.