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
Information provided by:
Medical University of Vienna Identifier:
First received: November 17, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted

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.

Condition Intervention Phase
Drug: Remifentanil
Drug: Midazolam
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of High-dose Remifentanil on Established Sunburn-induced Hyperalgesia in Human Volunteers (HighDose RemiSun)

Resource links provided by NLM:

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Measure: Area of pin prick hyperalgesia [ Time Frame: 0-6h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: November 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Remifentanil
Remifentanil Infusion
Drug: Remifentanil
Remifentanil Infusion
Other Name: Ultiva
Active Comparator: Midazolam
Active Placebo
Drug: Midazolam
Midazolam Infusion
Other Name: Dormicum


Ages Eligible for Study:   19 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01015482

Department of Anaesthesia, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Michael H Andreae, MD    +436769677181   
Contact: Brigitte E Scheffold    +43140400 ext 2221   
Principal Investigator: Astrid Chiari, MD         
Sub-Investigator: Burkhard Gustorff, MD         
Sub-Investigator: Michael H Andreae, MD         
Sub-Investigator: Brigitte E Scheffold         
Sub-Investigator: Jürgen Sandkühler, MD PHD         
Sub-Investigator: Ruth Drdla, PHD         
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Astrid Chiari, MD Medical University of Vienna
  More Information

Additional Information:
Responsible Party: Professor Burkhard Gustorff, Medical University of Vienna, Dept. Anaesthesia Identifier: NCT01015482     History of Changes
Other Study ID Numbers: HighDose RemiSun 
Study First Received: November 17, 2009
Last Updated: November 17, 2009
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:

Additional relevant MeSH terms:
Nervous System Diseases
Neurologic Manifestations
Sensation Disorders
Signs and Symptoms
Somatosensory Disorders
Adjuvants, Anesthesia
Analgesics, Opioid
Anesthetics, General
Anesthetics, Intravenous
Anti-Anxiety Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Tranquilizing Agents processed this record on May 24, 2016