Capsaicin 8% Patch Treatment for Chronic Neuropathic Pain After Surgery or Trauma in Children Ages 12 to 17

What this Trial Is About

This research aims to evaluate the effectiveness of the Capsaicin 8% cutaneous patch compared to a hydrocolloid dressing in children aged 12 to 17 years who have local chronic neuropathic pain lasting more than three months after trauma or surgery. The study is a multicenter, randomized controlled trial designed to assess pain relief and safety in this pediatric population. Participants include children with persistent neuropathic pain despite oral treatments or those with less severe pain without prior oral treatment. Participants receive either the Capsaicin 8% patch or a hydrocolloid dressing applied to intact, non-irritated, dry skin at baseline. If needed, a second application is done three months later. The patch is applied for 30 minutes on the feet or 60 minutes on other body areas. Tolerance to the treatment is monitored during and after each application, including phone follow-ups until cold need stops. Children are followed monthly for four months after the first application through clinical consultations to assess effectiveness. Assessments include the Neuropathic Pain Symptom Inventory score, adverse event monitoring, vital signs, dermal evaluations, pain related to treatment, use of analgesics, and functional disability. The total participation duration is approximately four months with regular monitoring to evaluate both safety and efficacy outcomes.

Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children