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Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children
Sponsor: University Hospital, Brest
Summary
This study concerns children aged to 12 to 17-years with local chronic neuropathic pain after trauma or surgery. It is a multicentric randomized controlled superiority trial in parallel arms : * experimental arm: Capsaicin 8% cutaneous patch * controlled arm : Hydrocolloid dressing Treatment with capsaicin application is realized at baseline, and repeated 3 months after the first patch application if needed. Tolerance is assessed during each application and by phone call in following days until stop of cold need. Efficacy is assessed monthly by clinical consultation until the end of the study (month 4).
Official title: Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch for the Treatment of Chronic Postsurgical or Post-traumatic Neuropathic Pain: a Randomized Placebo Controlled Study in Children Aged 12 to 17-y
Key Details
Gender
All
Age Range
12 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
46
Start Date
2024-03-05
Completion Date
2026-04-05
Last Updated
2025-12-17
Healthy Volunteers
No
Conditions
Interventions
Capsaicin 8% patch
Patients will receive Capsaicin 8% patch at the inclusion of the study and three months later if it is necessary (persistant pain). Qutenza should be applied to intact, non-irritated, dry skin, and during 30 minutes for the feet or 60 minutes for other areas of the body.
Hydrocolloid dressing
Patients will receive Hydrocolloid dressing at the inclusion of the study and three months later if it is necessary (persistant pain). Hydrocolloid dressing should be applied to intact, non-irritated, dry skin, and during 30 minutes for the feet or 60 minutes for other areas of the body.
Locations (10)
CHU d'Amiens
Amiens, France
CHU d'Angers
Angers, France
CHU de Bordeaux
Bordeaux, France
CHU de Brest
Brest, France
CHU de Nantes
Brest, France
CHU de Lyon
Lyon, France
CHU de Marseille
Marseille, France
CHU de Montpellier
Montpellier, France
CHU de Tours
Tours, France
Institut Gustave Roussy
Villejuif, France