Volunteer study with 24 healthy volunteers to perform pain research and to study the reversal of hyperalgesia by IMP
Conditions
Sponsors
Abteilung für Anästhesie und Intensivmedizin, Medizinische Universität Wien
Eligibility
Sex/Gender
All
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Mechanical pain threshold within the area of pin prick hyperalgesia area of dynamic allodynia to brush, heat pain perception threshold SR-function to dynamic mechanical stimuli Superficial blood flow (sBF) in the hyperalgesic area | — |
Countries
Austria
Outcome results
None listed