Observational Study of the Use of 8% Capsaicin Patch in Children 0 to 18 Years Old
- Conditions
- Neuropathic PainChronic Pain
- Registration Number
- NCT05299294
- Lead Sponsor
- University Hospital, Brest
- Brief Summary
Patients aged less than 18-y with validated 8% capsaicin patch treatment in routine healthcare will be offered to participate the study. If they accept it as well as their parents, they will be included in the study .
Medical data will be recorded and at home, the child or his family will collect pain assessment data.
Tolerance will be monitored at home by phone call from investigational team every 24 hours until normalization. (Less than 24 hours for 75%, 100% to 72 hours on unpublished personal series.) Children will be assessed via scales at inclusion and 1-month, 3-month and 6-month.
- Detailed Description
Children and teenagers aged less than 18-y, with chronic localized neuropathic pain, may be treated by capsaicin 8% patch. If this indication is validated in pediatric chronic pain consultation, they will be offered to participate the study. If they accept it as well as their parents, they will be included in the study.
Treatment application will follow recommendations and be realized in out patient clinic with trained nurses.
Tolerance will be assessed by phone call every 24 Hours by investigational team until normalization. Expected duration is less than 24 Hours for 75% patients and 100 % at 72 Hours, from unpublished personal data.
Efficacy will be monitored with usual pain and neuropathic pain tools, adapted to age and cognitive capacities, one month after application.
Treatment may be done three times if needed with a three month interval between each capsaicin patch application.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
- chronic localized neuropathic pain
- capsaicin 8% patch treatment indication validated in a pediatric chronic pain center
- agreement for participation by child and parents
- already treated with capsaicin 8% patch in the same body area
- already treated in the same study in an other investigation center
- non willing to participate or parents not willing participation to the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Success or failure of pain treatment : Number of patients with success and number of patients with failure of treatment with capsaicin 3 months after last patch application The success is defined by the absence of use of pain medication during the three months after the end of capsaicin application protocol
- Secondary Outcome Measures
Name Time Method Indication of capsaicin use At recruitment visit Indication for treatment with capsaicine will be collected (context of emergence of pain, descriptive data)
Neuropathic pain description for child aged from 5 to 11 years Baseline and 1 month, 3 months and 6 months after patch application. Global score and subscores of NPSI (Neuropathic Pain Syndrome Inventory), questionnaire with support, score from 0 to 100, higher score is worse outcome
Neuropathic pain description for child aged from 12 to 17 years Baseline and 1 month, 3 months and 6 months after patch application. Global score and subscores of NPSI (Neuropathic Pain Syndrome Inventory) questionnaire without support, score from 0 to 100, higher score is worse outcome
Pain description (sleep quality) for child aged from 0 to 4 years or with intellectual deficiency Baseline and 1 month, 3 months and 6 months after patch application. Description of sleep quality (night awakening / week)
Success or failure of pain treatment : Number of patients who use or not use antalgic and/or comfort medication (including for improving sleep) Baseline and 1 month, 3 months and 6 months after patch application. Use of antalgic and/or comfort medication (including for improving sleep). Success is de fined by the non use of antalgic and/or comfort medication (including for improving sleep)
Neuropathic pain evaluation for child with intellectual deficiency Baseline, 3 months, 6 months and 1 month, 3 months and 6 months after patch application. Score of PAGID (Pain Assessment Grid - Intellectual Deficiency) or PPP (Pediatric Pain Profile) questionnaire, higher scores are worse outcome
Neuropathic pain evaluation for child aged from 5 to 11 years Baseline, 3 months, 6 months and 1 month, 3 months and 6 months after patch application. Score of pVAS (Paediatric Visual Analogic Scale) or NS (Numeric Scale) or Revised Faces Pain Scales, score from 0 to 10, higher score is worse outcome
Tolerance assessment (duration of patch application) Baseline, 3 months and 6 months Duration of patch application in minutes
Tolerance assessment (skin aspect) Baseline, 3 months and 6 months : 4, 8, 24, 48 and 72 hours after patch application Local aspect of skin : presence of erythema Yes or No, in the hours and days following patch application
Neuropathic pain evaluation for child aged from 0 to 4 years Baseline, 3 months, 6 months and 1 month, 3 months and 6 months after patch application. Score of HECP (Hetero-Evaluation of Child Pain) questionnaire, score from 0 to 10 (a higher score means a worse outcome)
Neuropathic pain evaluation for child aged from 12 to 17 years Baseline, 3 months, 6 months and 1 month, 3 months and 6 months after patch application. Score of VAS (Visual Analogic Scale) or NS (Numeric Scale), score from 0 to 10, higher score is worse outcome
Pain description (observed signs) for child aged from 0 to 4 years or with intellectual deficiency Baseline and 1 month, 3 months and 6 months after patch application. Description of observed signs related to pain
Pain description (child behaviour) for child aged from 0 to 4 years or with intellectual deficiency Baseline and 1 month, 3 months and 6 months after patch application. Description of child behaviour related to pain (antalgic position)
Tolerance assessment (cutaneous state) Baseline, 3 months and 6 months Cutaneous state (burning, erythema, healthy skin, other) just after patch removal
Tolerance assessment (icing) Baseline, 3 months and 6 months : 4, 8, 24, 48 and 72 hours after patch application Need for icing (YES/NO) against pain
Neuropathic pain diagnostic for child aged from 5 to 11 years Baseline and 1 month, 3 months and 6 months after patch application. Global score of pPN4 (Paediatric Neuropathic Pain 4 points) questionnaire, score from 0 to 10, higher score is worse item
Pain description for child aged from 5 to 17 years : number of painful access Baseline and 1 month, 3 months and 6 months after patch application. Number of painful access (crisis) in one day
Pain description for child aged from 5 to 17 years : duration of painful access Baseline and 1 month, 3 months and 6 months after patch application. Mean duration of painful access (crisis) in minutes
Tolerance assessment (number of patch used) Baseline, 3 months and 6 months Number of patch used during the application
Neuropathic pain diagnostic for child aged from 12 to 17 years Baseline and 1 month, 3 months and 6 months after patch application. Global score of NP4 questionnaire (Neuropathic Pain 4 points), score from 0 to 10, higher score is worse item
Functional disability evaluation for child aged from 5 to 17 years Baseline and 1 month, 3 months and 6 months after patch application. Global score of FDI (Functional Disability Inventory) questionnaire, score from 0 to 60, higher score is worse outcome
Pain description for child aged from 5 to 17 years : trigger factor of the painful access Baseline and 1 month, 3 months and 6 months after patch application. Type of trigger factor that leads to the painful access
Pain description for child aged from 5 to 17 years : sensation Baseline and 1 month, 3 months and 6 months after patch application. Description of sensation reported by the child (sensation spontaneously described, qualitative data)
Tolerance assessment (rescue medication) Baseline, 3 months and 6 months : 4, 8, 24, 48 and 72 hours after patch application Intake of rescue medication against pain (YES/NO)
Trial Locations
- Locations (20)
CHR Bourg en Bresse
🇫🇷Bourg-en-Bresse, France
CHU Montpellier
🇫🇷Montpellier, France
CHU d'Amiens
🇫🇷Amiens, France
CHU Bordeaux
🇫🇷Bordeaux, France
CHU de Brest
🇫🇷Brest, France
CHU Grenoble
🇫🇷Grenoble, France
CHU Limoges
🇫🇷Limoges, France
CHU Caen
🇫🇷Caen, France
CHU Lille
🇫🇷Lille, France
CHU Nancy
🇫🇷Nancy, France
CHU Nantes
🇫🇷Nantes, France
CHU Trousseau
🇫🇷Paris, France
Institut Gustave Roussy
🇫🇷Villejuif, France
CHU Toulouse
🇫🇷Toulouse, France
CHU Rouen
🇫🇷Rouen, France
CHU Lyon
🇫🇷Lyon, France
CHU Angers
🇫🇷Angers, France
CHU Marseille
🇫🇷Marseille, France
CHU Robert Debré
🇫🇷Paris, France
CHRU Strasbourg
🇫🇷Strasbourg, France