The effect of high dose remifentanil on the reversal of established sunburn-induced hyperalgesia in human volunteers - High-Dose-RemiSu

Conditions: Volunteer study with 24 healthy volunteers to perform pain research and to study the reversal of hyperalgesia by IMP

Registration Number: EUCTR2009-015780-14-AT

Lead Sponsor: Abteilung für Anästhesie 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

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 >135mmHg or diastolic blood pressure >85mmHg
History of allergy to any of the medications used in the study
Pregnancy or breast feeding
Acute skin diseases like sunburn or skin lesions on the relevant areas and UV sensitive skin conditions, like Xeroderma pigmentosa

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 (starting 24 hours after irradiation) until 6 hours after discontinuation of IMP;Main Objective: To study that sunburn induced mechanical hyperalgesia is reversed by highdose remifentanil. Main outcome variable: area of pin prick hyperalgesia.;Secondary Objective: (SR)-function to a set of rigid von Frey filaments <br>Mechanical pain threshold within the area of pin prick hyperalgesia<br>area of dynamic allodynia to brush, <br>heat pain perception threshold<br>SR-function to dynamic mechanical stimuli<br>Superficial blood flow (sBF) in the hyperalgesic area<br>

Secondary Outcome Measures