The Effect of Remifentanil on Established Capsaicin-Induced Hyperalgesia in Human Volunteers (RemiCaps2)
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|ClinicalTrials.gov Identifier: NCT00789386|
Recruitment Status : Unknown
Verified May 2009 by Medical University of Vienna.
Recruitment status was: Recruiting
First Posted : November 11, 2008
Last Update Posted : May 21, 2009
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.
Intradermal injection of capsaicin (injection of pepper extract into the skin) is an established pain model in humans. The investigators want to test the influence of remifentanil, an ultra-short acting opioid, on hyperalgesia observed after intradermal capsaicin in human volunteers in a double blind cross-over prospective active placebo controlled clinical trial.
|Condition or disease||Intervention/treatment||Phase|
|Hyperalgesia||Drug: Remifentanil Drug: Midazolam||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||The Effect of Remifentanil on Established Capsaicin-Induced Hyperalgesia in Human Volunteers|
|Study Start Date :||November 2008|
|Estimated Primary Completion Date :||October 2009|
|Estimated Study Completion Date :||December 2009|
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.
Placebo Comparator: 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.
- Area of pin prick hyperalgesia [ Time Frame: 0-6 hours ]
- Stimulus-response (SR)function to a set of modified rigid von Frey filaments (8-512 mN) [ Time Frame: 0-6 hours ]
- Pain immediately after injection [ Time Frame: 0-15 minutes ]
- Heat pain threshold within the area of mechanical hyperalgesia [ Time Frame: 0-6 hours ]
- Mechanical pain threshold within the area of pin prick hyperalgesia, area of dynamic allodynia to brush [ Time Frame: 0-6 hours ]
- Adverse effects [ Time Frame: 10 and 30 min after infusion of study medication ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00789386
|Contact: Michael H Andreae, MDfirstname.lastname@example.org|
|Contact: Bernd Schudermaier, M.Pharm||+43140400 ext email@example.com|
|Department of Anaesthesia, Medical University of Vienna||Recruiting|
|Vienna, Austria, 1090|
|Principal Investigator: Astrid Chiari, MD|
|Sub-Investigator: Burkhard Gustorff, MD|
|Sub-Investigator: Bernd Schmudermaier, MSc. Pharm|
|Sub-Investigator: Martin Schmudermaier, MD|
|Sub-Investigator: Michael H Andreae, MD|
|Sub-Investigator: Hanna Opelt, MD|
|Sub-Investigator: Stephan Stellnberger, MD|
|Sub-Investigator: Juergen Sandkuehler, MD, PHD|
|Sub-Investigator: Ruth Drdla, PHD|
|Study Chair:||Burkhard Gustorff, MD||Medical University of Vienna|