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Topical Local Anaesthesia and Cooling During Capsaicin 8% Patch Application

Information source: Medical University of Vienna
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Phase: N/A

Status: Completed

Sponsored by: Medical University of Vienna

Summary

Aim of the study is to demonstrate superiority of a continuous cooling of the skin over topical EMLA or placebo in reducing the burning pain during the application of capsaicin 8% patch ("Qutenza"). Secondary it will be tested, if the 2 different pre-treatments have an effect on the application pain within the first 24 hours, and if different pre-treatments have an effect on the reduction of the epidermal nerve fiber density (ENFD) 1 week after Qutenza application.

Clinical Details

Official title: A Comparison of Topical Local Anaesthesia and Cooling to Reduce the Burning Pain During Capsaicin 8% Patch Application

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: burning pain during the application of capsaicin 8% patch

Secondary outcome:

application pain within the first 24 hours after application of capsaicin 8% patch

epidermal nerve fiber density(ENFD)

Detailed description: According to literature, one of the most common adverse events of capsaicin 8% patch is a burning pain and a reversible erythema at the application site. In general it is recommended to apply a topical anesthetic one hour before capsaicin 8% patch application, or to treat the pain with cooling, NSAIDs or even opioids. Nevertheless, there is still only limited data available on the effects and side-effects. In this study it shall be tested if cooling the skin down for about 5-10 Celsius, immediately before Qutenza is applied, and continuing the cooling during the whole application time, results in a reliable prevention of the burning pain compared to pretreatment with topical anesthesia applied one hour in advance. This would lead to the assumption that the application pain is predominantly caused by a decrease of the threshold for heat pain beyond skin temperature and can therefore be prevented by a lowering of the skin temperature. By ascertaining pain 24 hours after capsaicin 8% patch application and epidermal nerve fiber density (ENFD) 1 week after capsaicin 8% patch application it shall be proved if the different pretreatment methods do not change the secondary effects of capsaicin application. If results turn out to be positive, it would be a massive relief with regard to time management and rescue medication.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- healthy volunteers 18 ore more years old

Exclusion Criteria:

- dermatologic or neurologic injuries on both thighs

Locations and Contacts

Dept. of Spec. Anesthesia and Pain Therapy, Vienna 1090, Austria
Additional Information

Starting date: January 2012
Last updated: March 19, 2012

Page last updated: August 23, 2015

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