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

Regional University Hospital Center (CHRU)

Status: Enrolling

Conditions: Neuropathic Pain; Chronic Pain

Treatments: Other: Data collection

Study type: Observational

Funder types: Other

Identifiers

NCT05299294

29BRC21.0184 (CAPSULE)

Details and patient eligibility

About

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 (Less than 24 hours for 75%, 100% to 72 hours on unpublished personal series.)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

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 Expected duration is less than 24 Hours for 75% patients and 100 % at 72 Hours, from unpublished personal data.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

Enrollment: 160 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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