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
Recruitment status was Recruiting
Sponsor:
Medical University of Vienna
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
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Purpose
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 |
|---|---|---|
|
Hyperalgesia |
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
|
Eligibility| Ages Eligible for Study: | 19 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015482
Locations
| Austria | |
| Department of Anaesthesia, Medical University of Vienna | Recruiting |
| Vienna, Austria, 1090 | |
| Contact: Michael H Andreae, MD +436769677181 michael@andreae.org | |
| Contact: Brigitte E Scheffold +43140400 ext 2221 brigitte.scheffold@web.de | |
| 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
Investigators
| Principal Investigator: | Astrid Chiari, MD | Medical University of Vienna |
More Information
Additional Information:
No publications provided
| Responsible Party: | Professor Burkhard Gustorff, Medical University of Vienna, Dept. Anaesthesia |
| ClinicalTrials.gov 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:
|
Sunburn Remifentanil Hyperalgesia |
Additional relevant MeSH terms:
|
Hyperalgesia Sunburn Somatosensory Disorders Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms Photosensitivity Disorders Skin Diseases Burns Wounds and Injuries Midazolam Remifentanil Adjuvants, Anesthesia Central Nervous System Agents |
Therapeutic Uses Pharmacologic Actions Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013