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Sponsored by: |
Medical University of Vienna |
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Information provided by: | Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT00789386 |
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 a previously unrecognized effect of opioids, the reversal of these long term changes.
Intradermal injection of capsaicin (injection of pepper extract into the skin) is an established pain model in humans. The investigators want to test the hypothesis, that remifentanil, an ultra-short acting opioid, can reverse the hyperalgesia observed after intradermal capsaicin in human volunteers in a double blind cross-over prospective active placebo controlled clinical trial.
Condition | Intervention | Phase |
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Hyperalgesia |
Drug: Remifentanil Drug: Midazolam |
Phase IV |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | The Effect of Remifentanil on the Reversal of Established Capsaicin-Induced Hyperalgesia in Human Volunteers |
Estimated Enrollment: | 24 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Remifentanil: Experimental |
Drug: Remifentanil
Remifentanil (Ultiva ®; Glaxo-Smith-Kline; Vienna, Austria) at an initial dose of 0.24 µg kg-1 min-1 will be applied iv during 60 minutes.
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Midazolam: Placebo Comparator
Active Placebo
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Drug: Midazolam
Midazolam (Dormicum®; Roche; Vienna, Austria) will be applied iv as active placebo at a dose of 7.5 µg.kg-1.min-1 over 10 minutes to mimic typical central nervous side effects of remifentanil.
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Ages Eligible for Study: | 19 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael H Andreae, MD | +436769677181 | michael@andreae.org |
Contact: Bernd Schudermaier, M.Pharm | +43140400 ext 6428 | bernd.schmudermaier@meduniwien.ac.at |
Austria | |
Department of Anaesthesia, Medical University of Vienna | Recruiting |
Vienna, Austria, 1090 | |
Principal Investigator: Burkhard Gustorff, MD | |
Sub-Investigator: Michael H Andreae, MD |
Principal Investigator: | Burkhard Gustorff, MD | Medical University of Vienna |
Responsible Party: | Vienna Human Pain Research Group, Department of Anaesthesia, Medical University of Vienna ( Professor Burkhard Gustorff ) |
Study ID Numbers: | VHPRG-RemiCaps2, LS07-040 |
Study First Received: | November 10, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00789386 |
Health Authority: | Austria: Federal Office for Safety in Health Care |
Capsaicin Remifentanil Hyperalgesia |
Signs and Symptoms Sensation Disorders Somatosensory Disorders Remifentanil |
Neurologic Manifestations Midazolam Capsaicin Hyperalgesia |
Anesthetics, Intravenous Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Anesthetics Central Nervous System Depressants Pharmacologic Actions Adjuvants, Anesthesia |
Anesthetics, General Sensory System Agents Therapeutic Uses Hypnotics and Sedatives GABA Agents Antipruritics Anti-Anxiety Agents Analgesics Peripheral Nervous System Agents Dermatologic Agents Central Nervous System Agents Analgesics, Opioid |