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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: March 2010

Interventions

  • Drug: Remifentanil
    • Remifentanil Infusion
  • Drug: Midazolam
    • Midazolam Infusion

Arms, Groups and Cohorts

  • Experimental: Remifentanil
    • Remifentanil Infusion
  • Active Comparator: Midazolam
    • Active Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Measure: Area of pin prick hyperalgesia
    • Time Frame: 0-6h

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Medical University of Vienna
  • Provider of Information About this Clinical Study
    • Professor Burkhard Gustorff, Medical University of Vienna, Dept. Anaesthesia
  • Overall Official(s)
    • Astrid Chiari, MD, Principal Investigator, Medical University of Vienna

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