Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children (CAPSAPED)
Neuropathic Pain, Chronic Pain
About this trial
This is an interventional treatment trial for Neuropathic Pain focused on measuring Neuropathic Pain, Pediatric, Capsaicin, Randomized clinical trial
Eligibility Criteria
Inclusion Criteria: Children aged 12 to 17 years (lower age limit of 12 has been chosen to ensure NPSI full filling). Male or female. Persistent neuropathic pain more than 3 months after surgery or trauma despite treatment following recommendations. Neuropathic pain is defined as a DN4 score equal to or greater than 3/7 or 4/10, and localized in a nerve territory explained by the surgery or the trauma. Treatment, survey and follow up must be realized in an identified investigating center of the study For patients of childbearing potential: use of an adequate method of contraception* during the course of the study through 48 hours after the last patch application (girls of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to the first patch application). Adequate contraception includes sexual abstinence, progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide, combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods) Exclusion Criteria: Intellectual deficiency not allowing full filling of NPSI. Insufficient command of the French language to full fill NPSI and other evaluation tools. Parents' refusal of consent. Minor patients' opposition. Underlying neurological disease. Ongoing neurotoxic treatment. Already treated by capsaicin. Cutaneous lesion on pain area. Patient presenting a pain area on the face, above the hairline of the scalp, and/or in proximity to mucous membranes Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of Qutenza SmPC.
Sites / Locations
- CHU d'Amiens
- CHU d'Angers
- CHU de Bordeaux
- CHU de Brest
- CHU de Nantes
- CHU de Lyon
- CHU de Marseille
- CHU de Montpellier
- CHU de Toulouse
- Institut Gustave Roussy
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
QUTENZA
Placebo
The experimental product is QUTENZA®, a cutaneous patch which contains 179 mg of capsaicin (capsaicin 8%).The patch measures 14 cm x 20 cm. The second application takes place three months after the first application.
The placebo comparator is a hydrocolloid dressing: COMFEEL PLUS TRANSPARENT, a medical device class IIb commercialized by Coloplast. The patch measures 15 cm x 15 cm. The second application takes place three months after the first application.