The Effect of High-dose Remifentanil on Established Capsaicin-induced Hyperalgesia in Human Volunteers
Information source: Medical University of Vienna
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperalgesia
Intervention: Remifentanil (Drug); Midazolam (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Medical University of Vienna Official(s) and/or principal investigator(s):
Burkhard Gustorff, MD, Study Chair, Affiliation: Medical University of Vienna
Overall contact:
Michael Andreae, MD, Phone: +436769677181, Email: michael@andreae.org
Summary
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.
Clinical Details
Official title: The Effect of High-dose Remifentanil on Established Capsaicin-induced Hyperalgesia in Human Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science
Primary outcome: Area of pin prick hyperalgesia
Secondary outcome: Pain immediately after injectionStimulus-response (SR) function to a set of modified rigid von Frey filaments (8-512 mN) Heat pain threshold within the area of mechanical hyperalgesia Mechanical pain threshold within the area of pin prick hyperalgesia, area of dynamic allodynia to brush Adverse effects
Eligibility
Minimum age: 19 Years.
Maximum age: 40 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Men or women, aged between 19 and 40 years
- 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
- Regular consumption of very spicy (capsaicin containing) food
- Allergy against any medication used in the study protocol
Locations and Contacts
Michael Andreae, MD, Phone: +436769677181, Email: michael@andreae.org
Department of Anaesthesia, Medical University of Vienna, Vienna 1090, Austria; Recruiting
Michael Andreae, MD, Phone: +436769677181, Email: michael@andreae.org
Stephan Stellnberger, MD, Phone: +436507333189, Email: stephan.stellnberger@meduniwien.ac.at
Astrid Chiari, MD, Principal Investigator
Burkhard Gustorff, MD, Sub-Investigator
Michael H Andreae, MD, Sub-Investigator
Stephan Stellnberger, MD, Sub-Investigator
Hanna Opelt, MD, Sub-Investigator
Juergen Sandkuehler, MD, PHD, Sub-Investigator
Ruth Drdla, PHD, Sub-Investigator
Additional Information
Vienna Human Pain Research Group
Starting date: June 2009
Last updated: November 17, 2009
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