The effect of remifentanil on the reversal of established capsaicin-induced hyperalgesia in human volunteers
- Conditions
- This is a volunteer study in healthy volunteers. Pain research, reversal of hyperalgesia by IMP is studied.
- Registration Number
- EUCTR2008-003605-13-AT
- Lead Sponsor
- Abteilung für Anaesthesie und Intensivmedizin, Medizinische Universität Wien
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Pregnancy
Any disease
Ongoing pain
Older than 40 years old
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Area of pin prick hyperalgesia 6 hours after stop of IMP;Main Objective: To study the reversal of established hyperalgesia.<br>The main outcome variable will be: area of pin prick hyperalgesia.;Secondary Objective: To study the reversal effect on additional outcome variables for mechanical hyperalgesia will be:<br>Stimulus response (SR)-function to a set of modified rigid von Frey filaments (8-512mN), area of dynamic allodynia to brush and SR-function to dynamic mechanical stimuli.<br>Pain immediately after injection and heat pain threshold within the area of mechanical hyperalgesia will serve as additional outcome variables.
- Secondary Outcome Measures
Name Time Method