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