The effect of high-dose remifentanil on the reversal of established capsaicin-induced hyperalgesia in human volunteers

Phase 1

Conditions: This is a volunteer study in healthy volunteers. Pain research, reversal of hyperalgesia by IMP ist studied

Registration Number: EUCTR2009-011599-31-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

Any of the following will exclude a subject from the study:
•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
•Pregnancy or breast feeding

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study the reversal of established hyperalgesia<br>The main outcome variable will be: area of pin prick hyperalgesia<br>;Secondary Objective: To study the reversal effect on additional outcome variables for mechanical hyperalgesia will be: Stimulus response (SR-)function to set of modified rigid Frey filaments, area of dynamic allodynia to brush. Heat pain threshold within the area of mechanical hyperalgesia will serve as additional outcome variable.<br>;Primary end point(s): Area of pinprick hyperalgesia 6 hours after discontinuation of IMP

Secondary Outcome Measures