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

Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: Medical University of Vienna

Current Primary Outcome: Measure: Area of pin prick hyperalgesia [ Time Frame: 0-6h ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Stimulus-response (SR) function to a set of modified rigid von Frey filaments (8-512 mN) [ Time Frame: 0-6h ]
  • Heat pain threshold within the area of mechanical hyperalgesia [ Time Frame: 0-6h ]
  • Mechanical pain threshold within the area of pin prick hyperalgesia, area of dynamic allodynia to brush [ Time Frame: 0-6h ]
  • Adverse effects [ Time Frame: 30 and 59 min after start of treatment ]


Original Secondary Outcome: Same as current

Information By: Medical University of Vienna

Dates:
Date Received: November 17, 2009
Date Started: November 2009
Date Completion: April 2010
Last Updated: November 17, 2009
Last Verified: November 2009