The Effect of Remifentanil on Established Capsaicin-Induced Hyperalgesia in Human Volunteers (RemiCaps2)
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||The Effect of Remifentanil on Established Capsaicin-Induced Hyperalgesia in Human Volunteers|
- Area of pin prick hyperalgesia [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]
- Stimulus-response (SR)function to a set of modified rigid von Frey filaments (8-512 mN) [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]
- Pain immediately after injection [ Time Frame: 0-15 minutes ] [ Designated as safety issue: No ]
- Heat pain threshold within the area of mechanical hyperalgesia [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]
- Mechanical pain threshold within the area of pin prick hyperalgesia, area of dynamic allodynia to brush [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]
- Adverse effects [ Time Frame: 10 and 30 min after infusion of study medication ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||December 2009|
|Estimated Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|