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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01015482
First received: November 17, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted

November 17, 2009
November 17, 2009
November 2009
March 2010   (final data collection date for primary outcome measure)
Measure: Area of pin prick hyperalgesia [ Time Frame: 0-6h ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Stimulus-response (SR) function to a set of modified rigid von Frey filaments (8-512 mN) [ Time Frame: 0-6h ] [ Designated as safety issue: No ]
  • Heat pain threshold within the area of mechanical hyperalgesia [ Time Frame: 0-6h ] [ Designated as safety issue: No ]
  • Mechanical pain threshold within the area of pin prick hyperalgesia, area of dynamic allodynia to brush [ Time Frame: 0-6h ] [ Designated as safety issue: No ]
  • Adverse effects [ Time Frame: 30 and 59 min after start of treatment ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Effect of High-dose Remifentanil on Established Sunburn-induced Hyperalgesia in Human Volunteers (HighDose RemiSun)
The Effect of High-dose Remifentanil on Established Sunburn-induced Hyperalgesia in Human Volunteers (HighDose RemiSun)

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Hyperalgesia
  • Drug: Remifentanil
    Remifentanil Infusion
    Other Name: Ultiva
  • Drug: Midazolam
    Midazolam Infusion
    Other Name: Dormicum
  • Experimental: Remifentanil
    Remifentanil Infusion
    Intervention: Drug: Remifentanil
  • Active Comparator: Midazolam
    Active Placebo
    Intervention: Drug: Midazolam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
April 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
19 Years to 40 Years
Yes
Austria
 
NCT01015482
HighDose RemiSun
No
Professor Burkhard Gustorff, Medical University of Vienna, Dept. Anaesthesia
Medical University of Vienna
Not Provided
Principal Investigator: Astrid Chiari, MD Medical University of Vienna
Medical University of Vienna
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP