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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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 (Less than 24 hours for 75%, 100% to 72 hours on unpublished personal series.)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

Eligibility

Primary outcome measure(s)

• Success or failure of pain treatment — 6 months after last patch application
  The success is defined by the absence of use of pharmacological or non-pharmacological treatments taken for pain relief or to improve comfort, including to aid sleep, 6 months after capsaicin last patch application. The list of treatments is defined as follows: antiepileptic drug, tricyclic antidepressant, SNRI antidepressant, weak opioids, strong opioids, other pharmacological treatments, non-pharmacological pain-related devices.

Trial sites (20)

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