Observational Study of the Use of 8% Capsaicin Patch in Children 0 to 18 Years Old

Study Overview
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Brief Summary
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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 (Less than 24 hours for 75%, 100% to 72 hours on unpublished personal series.)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
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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 Expected duration is less than 24 Hours for 75% patients and 100 % at 72 Hours, from unpublished personal data.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.

Official Title
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Observational Study of the Use of 8% Capsaicin Patch in Children 0 to 18 Years

Conditions
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Neuropathic Pain, Chronic Pain

Intervention / Treatment
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* Other: Data collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic localized neuropathic pain capsaicin 8% patch treatment indication validated in a pediatric chronic pain center agreement for participation by child and parents Exclusion Criteria: 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

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Data collection|Collecting data on children receiving capsaicine 8% patch for localized neuropathic pain|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success or failure of pain treatment : Number of patients with success and number of patients with failure of treatment with capsaicin | The success is defined by the absence of use of pain medication during the three months after the end of capsaicin application protocol | 3 months after last patch application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indication of capsaicin use | Indication for treatment with capsaicine will be collected (context of emergence of pain, descriptive data) | At recruitment visit | 
| Success or failure of pain treatment : Number of patients who use or not use antalgic and/or comfort medication (including for improving sleep) | 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) | Baseline and 1 month, 3 months and 6 months after patch application. | 
| Neuropathic pain evaluation for child aged from 0 to 4 years | Score of HECP (Hetero-Evaluation of Child Pain) questionnaire, score from 0 to 10 (a higher score means a worse outcome) | Baseline, 3 months, 6 months and 1 month, 3 months and 6 months after patch application. | 
| Neuropathic pain evaluation for child with intellectual deficiency | Score of PAGID (Pain Assessment Grid - Intellectual Deficiency) or PPP (Pediatric Pain Profile) questionnaire, higher scores are worse outcome | Baseline, 3 months, 6 months and 1 month, 3 months and 6 months after patch application. | 
| Neuropathic pain description for child aged from 5 to 11 years | Global score and subscores of NPSI (Neuropathic Pain Syndrome Inventory), questionnaire with support, score from 0 to 100, higher score is worse outcome | Baseline and 1 month, 3 months and 6 months after patch application. | 
| Neuropathic pain diagnostic for child aged from 5 to 11 years | Global score of pPN4 (Paediatric Neuropathic Pain 4 points) questionnaire, score from 0 to 10, higher score is worse item | Baseline and 1 month, 3 months and 6 months after patch application. | 
| Neuropathic pain evaluation for child aged from 5 to 11 years | 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 | Baseline, 3 months, 6 months and 1 month, 3 months and 6 months after patch application. | 
| Neuropathic pain description for child aged from 12 to 17 years | Global score and subscores of NPSI (Neuropathic Pain Syndrome Inventory) questionnaire without support, score from 0 to 100, higher score is worse outcome | Baseline and 1 month, 3 months and 6 months after patch application. | 
| Neuropathic pain evaluation for child aged from 12 to 17 years | Score of VAS (Visual Analogic Scale) or NS (Numeric Scale), score from 0 to 10, higher score is worse outcome | Baseline, 3 months, 6 months and 1 month, 3 months and 6 months after patch application. | 
| Neuropathic pain diagnostic for child aged from 12 to 17 years | Global score of NP4 questionnaire (Neuropathic Pain 4 points), score from 0 to 10, higher score is worse item | Baseline and 1 month, 3 months and 6 months after patch application. | 
| Functional disability evaluation for child aged from 5 to 17 years | Global score of FDI (Functional Disability Inventory) questionnaire, score from 0 to 60, higher score is worse outcome | Baseline and 1 month, 3 months and 6 months after patch application. | 
| Pain description for child aged from 5 to 17 years : number of painful access | Number of painful access (crisis) in one day | Baseline and 1 month, 3 months and 6 months after patch application. | 
| Pain description for child aged from 5 to 17 years : duration of painful access | Mean duration of painful access (crisis) in minutes | Baseline and 1 month, 3 months and 6 months after patch application. | 
| Pain description for child aged from 5 to 17 years : trigger factor of the painful access | Type of trigger factor that leads to the painful access | Baseline and 1 month, 3 months and 6 months after patch application. | 
| Pain description for child aged from 5 to 17 years : sensation | Description of sensation reported by the child (sensation spontaneously described, qualitative data) | Baseline and 1 month, 3 months and 6 months after patch application. | 
| Pain description (observed signs) for child aged from 0 to 4 years or with intellectual deficiency | Description of observed signs related to pain | Baseline and 1 month, 3 months and 6 months after patch application. | 
| Pain description (sleep quality) for child aged from 0 to 4 years or with intellectual deficiency | Description of sleep quality (night awakening / week) | Baseline and 1 month, 3 months and 6 months after patch application. | 
| Pain description (child behaviour) for child aged from 0 to 4 years or with intellectual deficiency | Description of child behaviour related to pain (antalgic position) | Baseline and 1 month, 3 months and 6 months after patch application. | 
| Tolerance assessment (duration of patch application) | Duration of patch application in minutes | Baseline, 3 months and 6 months | 
| Tolerance assessment (number of patch used) | Number of patch used during the application | Baseline, 3 months and 6 months | 
| Tolerance assessment (cutaneous state) | Cutaneous state (burning, erythema, healthy skin, other) just after patch removal | Baseline, 3 months and 6 months | 
| Tolerance assessment (skin aspect) | Local aspect of skin : presence of erythema Yes or No, in the hours and days following patch application | Baseline, 3 months and 6 months : 4, 8, 24, 48 and 72 hours after patch application | 
| Tolerance assessment (icing) | Need for icing (YES/NO) against pain | Baseline, 3 months and 6 months : 4, 8, 24, 48 and 72 hours after patch application | 
| Tolerance assessment (rescue medication) | Intake of rescue medication against pain (YES/NO) | Baseline, 3 months and 6 months : 4, 8, 24, 48 and 72 hours after patch application | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuropathic Pain, Pediatric, Capsaicin