Chronic Pain, Neuropathic Pain
Conditions
Keywords
Neuropathic Pain, Pediatric, Capsaicin
Brief 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 (Less than 24 hours for 75%, 100% to 72 hours on unpublished personal series.)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 Expected duration is less than 24 Hours for 75% patients and 100 % at 72 Hours, from unpublished personal data.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.
Interventions
OTHERData collection
Collecting data on children receiving capsaicine 8% patch for localized neuropathic pain
Sponsors
University Hospital, Brest
Fondation de France
Fondation Apicil
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of pharmacological treatment | Baseline | Use (yes/no) of at least one of these pharmacological treatments : antiepileptic, tricyclic antidepressant, SNRI antidepressant, weak opioid, strong opioid, other pharmacological treatment. |
| Use of antiepileptic treatment | Baseline | Use of antiepileptic treatment (yes/no). |
| Use of tricyclic antidepressant treatment | Baseline | Use of tricyclic antidepressant treatment (yes/no). |
| Use of SNRI antidepressant treatment | Baseline | Use of SNRI antidepressant treatment (yes/no). |
| Use of weak opioid treatment | Baseline | Use of weak opioid treatment (yes/no). |
| Use of strong opioid treatment | Baseline | Use of strong opioid treatment (yes/no). |
| Use of other pharmacological treatment | Baseline | Use of other pharmacological treatment (yes/no) |
| Use of non-pharmacological treatment | Baseline | Use (yes/no) of at least one of these non-pharmacological treatments : limitation of rubbing, mobility aid, restriction of movement, use of adapted tools, other non-pharmacological treatment. |
| Use of pharmocological or non-pharmacological treatment | Baseline | Use (yes/no) of at least one of these treatments : antiepileptic, tricyclic antidepressant, SNRI antidepressant, weak opioid, strong opioid, other pharmacological treatment, limitation of rubbing, mobility aid, restriction of movement, use of adapted tools, other non-pharmacological treatment. |
| Indication of capsaicin use | Baseline | Indication for treatment with capsaicin will be collected (context of emergence of pain). |
| Erythema | Baseline | Presence of erythema up to 120 hours after patch application (yes/no). |
| Cooling | Baseline | Use of cooling up to 120 hours after patch application (yes/no). |
| Duration of cooling | Baseline | Duration of cooling is defined according to the first time point at which cooling is permanently discontinued. (Example: if cooling is permanently discontinued at 48 hours, the duration of cooling is classified as "Less than 48 hours"). |
| Change in continuous pain | Baseline and 6 months after last patch application | Continuous pain will be measured with VAS (Visual Analogic Scale), paediatric VAS, NS (Numerical Scale) or Revised Faces Pain Scales depending on patient age. All ranges from 0 to 10. Higher score is worse outcome. |
| Change in intermittent pain | Baseline and 6 months after last patch application | Intermittent pain will be measured with VAS (Visual Analogic Scale), paediatric VAS, NS (Numerical Scale) or Revised Faces Pain Scales depending on patient age. All ranges from 0 to 10. Higher score is worse outcome. |
| Condition assessment | Baseline | DN4 questionnaire score. The score ranges from 0 to 10, with 10 indicating the worst outcome. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORPhilippe J Le Moine, MD
CHRU of Brest
Outcome results
None listed