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 (Less than 24 hours for 75%, 100% to 72 hours on unpublished personal series.)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.
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 Expected duration is less than 24 Hours for 75% patients and 100 % at 72 Hours, from unpublished personal data.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.
Study Type
OBSERVATIONAL
Enrollment
160
Collecting data on children receiving capsaicine 8% patch for localized neuropathic pain
CHU Angers
Angers, France, France
CHU Bordeaux
Bordeaux, France, France
CHR Bourg en Bresse
Bourg-en-Bresse, France, France
CHU de Brest
Brest, France, France
CHU Caen
Caen, France, France
CHU Lille
Lille, France, France
CHU Limoges
Limoges, France, France
CHU Marseille
Marseille, France, France
CHU Montpellier
Montpellier, France, France
CHU Nancy
Nancy, France, France
...and 10 more locations
Success or failure of pain treatment
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.
Time frame: 6 months after last patch application
Use of pharmacological treatment
Use (yes/no) of at least one of these pharmacological treatments : antiepileptic, tricyclic antidepressant, SNRI antidepressant, weak opioid, strong opioid, other pharmacological treatment.
Time frame: Baseline
Use of pharmacological treatment
Use (yes/no) of at least one of these pharmacological treatments : antiepileptic, tricyclic antidepressant, SNRI antidepressant, weak opioid, strong opioid, other pharmacological treatment.
Time frame: 6 months after last patch application
Use of antiepileptic treatment
Use of antiepileptic treatment (yes/no).
Time frame: Baseline
Use of antiepileptic treatment
Use of antiepileptic treatment (yes/no).
Time frame: 6 months after last patch application
Use of tricyclic antidepressant treatment
Use of tricyclic antidepressant treatment (yes/no).
Time frame: Baseline
Use of tricyclic antidepressant treatment
Use of tricyclic antidepressant treatment (yes/no).
Time frame: 6 months after last patch application
Use of SNRI antidepressant treatment
Use of SNRI antidepressant treatment (yes/no).
Time frame: Baseline
Use of SNRI antidepressant treatment
Use of SNRI antidepressant treatment (yes/no).
Time frame: 6 months after last patch application
Use of weak opioid treatment
Use of weak opioid treatment (yes/no).
Time frame: Baseline
Use of weak opioid treatment
Use of weak opioid treatment (yes/no).
Time frame: 6 months after last patch application
Use of strong opioid treatment
Use of strong opioid treatment (yes/no).
Time frame: Baseline
Use of strong opioid treatment
Use of strong opioid treatment (yes/no).
Time frame: 6 months after last patch application
Use of other pharmacological treatment
Use of other pharmacological treatment (yes/no)
Time frame: Baseline
Use of other pharmacological treatment
Use of other pharmacological treatment (yes/no)
Time frame: 6 months after last patch application
Use of non-pharmacological treatment
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.
Time frame: Baseline
Use of non-pharmacological treatment
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.
Time frame: 6 months after last patch application
Use of pharmocological or non-pharmacological treatment
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.
Time frame: Baseline
Use of pharmocological or non-pharmacological treatment
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.
Time frame: 6 months after last patch application
Indication of capsaicin use
Indication for treatment with capsaicin will be collected (context of emergence of pain).
Time frame: Baseline
Erythema
Presence of erythema up to 120 hours after patch application (yes/no).
Time frame: Baseline
Erythema
Presence of erythema up to 120 hours after patch application (yes/no).
Time frame: Month 3 if applicable
Erythema
Presence of erythema up to 120 hours after patch application (yes/no).
Time frame: Month 6 if applicable
Cooling
Use of cooling up to 120 hours after patch application (yes/no).
Time frame: Baseline
Cooling
Use of cooling up to 120 hours after patch application (yes/no).
Time frame: Month 6 if applicable
Cooling
Use of cooling up to 120 hours after patch application (yes/no).
Time frame: Month 3 if applicable
Duration of cooling
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").
Time frame: Baseline
Duration of cooling
Duration of cooling is defined as 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").
Time frame: Month 3 if applicable
Duration of cooling
Duration of cooling is defined as 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").
Time frame: Month 6 if applicable
Change in continuous pain
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.
Time frame: Baseline and 6 months after last patch application
Change in intermittent pain
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.
Time frame: Baseline and 6 months after last patch application
Condition assessment
DN4 questionnaire score. The score ranges from 0 to 10, with 10 indicating the worst outcome.
Time frame: Baseline
Condition assessment
NPSI questionnaire global score. The global score ranges from 0 to 100, with 100 indicating the worst outcome.
Time frame: Baseline
Condition assessment
NPSI questionnaire first subscore (superficial spontaneous pain). The subscore ranges from 0 to 10, with 10 indicating the worst outcome.
Time frame: Baseline
Condition assessment
NPSI questionnaire second subscore (deep spontaneous pain). The subscore ranges from 0 to 10, with 10 indicating the worst outcome.
Time frame: Baseline
Condition assessment
NPSI questionnaire third subscore (paroxysmal pain). The subscore ranges from 0 to 10, with 10 indicating the worst outcome.
Time frame: Baseline
Condition assessment
NPSI questionnaire forth subscore (evoked pain). The subscore ranges from 0 to 10, with 10 indicating the worst outcome.
Time frame: Baseline
Condition assessment
NPSI questionnaire fifth subscore (paresthesia / dysesthesia). The subscore ranges from 0 to 10, with 10 indicating the worst outcome.
Time frame: Baseline
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