Qutenza is an approved product for the treatment of pain due to postherpetic neuralgia and peripheral neuropathies. Since its application is painful, it is often necessary to give analgesics or local cooling pads to the patients during the 60 min treatment session. In this investigation, the analgesic properties of Aspirin will be investigated in healthy probands during Qutenza application
Conditions
Interventions
Trade Name: Aspirin akut
Product Name: Aspirin akut
Pharmaceutical Form: Chewable/dispersible tablet
INN or Proposed INN: ACETYLSALICYLIC ACID
Other descriptive name: ACETYLSALICYLIC ACID
Concentratio
Sponsors
Medizinische Universität Wien
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Age: 18-65 years, Healthy males No history of clinically relevant previous diseases Normal laboratory parameters Normal blood pressure Painfree 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 22 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Kidney and liver diseases Gastric and duodenal ulcerations Recent gastritis Diseases of the skin, in particular in the treatment area Infectious diseases Regular intake of analgesics, centrally acting drugs or anti-coagulants Pain on the day of treatment Use of analgesics on the day of treatment Infectious disease on the day of treatment Allergies to any of the study medication Allergic asthma Any surgical procedures planned during the next week after treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main outcome parameter is the intensity of pain (mean NRS) during the application of Qutenza® measured by an 11-part numerical rating scale ranging from 0-10 (NRS with 0 = no pain and 10 = worst pain imaginable) before, 15, 30, 45 and 60 min during application of Qutenza® and 10, 20 and 30 min after its removal. ;Secondary Objective: The secondary outcome parameters are a)requirement of rescue medication or cooling b)the influence of the pre-medication on pain thresholds and perception thresholds in the treated skin area ;Primary end point(s): The primary parameter, mean of visual analogue scale measurements taken at 15, 30, 45 and 60 minutes during Qutenza® application and 10, 30, 60 minutes after application will be analysed by the intention to treat principle, using analysis of variance for cross-over designs, including the factors ‚medication‘ (acetylsalicylic acid or placebo), ‚period‘, and a random proband effect. Since NrS is restricted to the range of 0 to 10, it can be assumed that data are free from outliers and the normal assumption is approximately fulfilled. Secondary analysis: analysis of NRS at different time points using analysis of variance for cross-over designs and repeated measurements etc. ;Timepoint(s) of evaluation of this end point: Follow up one day after the second Qutenza treatment (day 5), Blood pressure (RR), inspection of the treated skin areas, interview | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Additional medication during treatment;Timepoint(s) of evaluation of this end point: End of treatment 2 | — |
Countries
Austria
Contacts
Public ContactSekretariat der Abteilung für Spezi
Medizinische Universität Wien, Abteilung für Spezielle Anästhesie und Schmerztherapie
Outcome results
None listed