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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-12

Study Completion Date

2027-09-12

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 (Less than 24 hours for 75%, 100% to 72 hours on unpublished personal series.)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.

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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 Expected duration is less than 24 Hours for 75% patients and 100 % at 72 Hours, from unpublished personal data.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.

Conditions

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Neuropathic Pain Chronic Pain

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Data collection

Collecting data on children receiving capsaicine 8% patch for localized neuropathic pain

Intervention Type OTHER

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

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No