NCT05299294

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 160 (estimated)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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 (Less than 24 hours for 75%, 100% to 72 hours on unpublished personal series.)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 Expected duration is less than 24 Hours for 75% patients and 100 % at 72 Hours, from unpublished personal data.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

Conditions

• Neuropathic Pain
• Chronic Pain

Interventions

Type	Name	Description
OTHER	Data collection	Collecting data on children receiving capsaicine 8% patch for localized neuropathic pain

Timeline

• Start date: 2022-05-12
• Primary completion: 2027-05-12
• Completion: 2027-09-12
• First posted: 2022-03-29
• Last updated: 2024-09-24

Locations

20 sites across 1 country: France