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).
Children aged to 12 to 17-years monitored in pediatric pain outpatient clinics in the designed investigation centers for a local chronic neuropathic pain lasting more than 2 months after trauma or surgery are proposed to participate the trial. Children with persistant neuropathic pain (DN4 (Diagnostic Neuropathic Pain) \> or = 3/7 ou DN4 \>or = 4/10) despite oral treatment following recommendations for neuropathic pain may be enrolled in the study. For children not very painful (NRS-11 (Numeric Rating Scale) \< 7 and FDI (Functional Disability Inventory) \< 30) and without any oral treatment for neuropathic pain, the study may be proposed as first line treatment. If both the child and his/her parents accept the trial, he/she will be included in the study. It is a multicentric randomized controlled superiority trial in parallel arms : * experimental arm: Capsaicin 8% cutaneous patch * controlled arm : Hydrocolloid dressing At M0, take place : baseline evaluation, agreement consent signature, inclusion and randomization, as well as first treatment application either capsaicin cutaneous patch or hydrocolloid dressing. , If needed, the treatment may be done twice with a second application three months later (M3). 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 4 months later (M4).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
46
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.
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.
CHU d'Amiens
Amiens, France
RECRUITINGCHU d'Angers
Angers, France
RECRUITINGCHU de Bordeaux
Bordeaux, France
RECRUITINGCHU de Brest
Brest, France
RECRUITINGCHU de Nantes
Brest, France
RECRUITINGCHU de Lyon
Lyon, France
RECRUITINGCHU de Marseille
Marseille, France
RECRUITINGCHU de Montpellier
Montpellier, France
RECRUITINGCHU de Tours
Tours, France
RECRUITINGInstitut Gustave Roussy
Villejuif, France
RECRUITINGThe change in Neuropathic Pain Symptom Inventory score (NPSI)
The decrease in Neuropathic Pain Symptom Inventory score (NPSI) is evaluated before the first application (M0) of capsaicin or placebo and 4 months later (M4). NPSI (Neuropathic Pain Syndrome Inventory) is a questionnaire without support, score from 0 to 100, higher score is worse outcome.
Time frame: At baseline (day of the patch application) and 4 months after patch application
Adverse event monitoring
Adverse event monitoring are collected during patch application and by phone calls in the following days.
Time frame: At day 0, day 1, day 2, day 3 after patch application
Vital signs
Cardiac frequency in Bpm
Time frame: At baseline, Month 1, Month 2, Month 3 and Month 4
Vital signs
Arterial pressure in mmHg
Time frame: At baseline, Month 1, Month 2, Month 3 and Month 4
Dermal assessment
Dermal assessment is evaluated with question concerning the treated area (YES/NO)
Time frame: At baseline
Dermal assessment
Dermal assessment is evaluated with questions concerning the feel of the treated area (YES/NO)
Time frame: Month 1, Month 2, Month 3 and Month 4
Treatment related pain and use of analgesic medication
Intake of analgesic medication (YES/NO)
Time frame: At baseline, day 1, day 2, Month 1, Month 2, Month 3 and Month 4
Duration of patch application
Duration of patch application in minutes
Time frame: During patch application : at baseline and at Month 3 if it is applicable
Neuropathic Pain Symptom Inventory score (NPSI)
Global score and subscores of NPSI (Neuropathic Pain Syndrome Inventory) questionnaire without support, score from 0 to 100, higher score is worse outcome
Time frame: At baseline, Month 1, Month 2, Month 3 and Month 4
Functional disability evaluation (FDI)
Global score of FDI (Functional Disability Inventory) questionnaire, score from 0 to 60, higher score is worse outcome
Time frame: At baseline, Month 1, Month 2, Month 3 and Month 4
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