Clinical trial NCT05299294: Observational Study of the Use of 8% Capsaicin Patch in Children 0 to 18 Years Old
Official title: Observational Study of the Use of 8% Capsaicin Patch in Children 0 to 18 Years
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuropathic Pain
Chronic Pain
Keywords: Neuropathic Pain
Pediatric
Capsaicin
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: Fondation de France
name: Fondation Apicil
First posted: 2022-03-29
Enrollment: 160
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients aged less than 18-y with chronic localized neuropathic pain and capsaicin 8% patch indication validated in a pediatric chronic pain center.

patient with intellectual development disabilities are accepted

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 (Less than 24 hours for 75%, 100% to 72 hours on unpublished personal series.)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 Expected duration is less than 24 Hours for 75% patients and 100 % at 72 Hours, from unpublished personal data.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

Eligibility criteria: 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

Primary outcomes:
measure: Success or failure of pain treatment : Number of patients with success and number of patients with failure of treatment with capsaicin
timeFrame: 3 months after last patch application
Secondary outcomes:
measure: Indication of capsaicin use
timeFrame: At recruitment visit
measure: Success or failure of pain treatment : Number of patients who use or not use antalgic and/or comfort medication (including for improving sleep)
timeFrame: Baseline and 1 month, 3 months and 6 months after patch application.
measure: Neuropathic pain evaluation for child aged from 0 to 4 years
timeFrame: Baseline, 3 months, 6 months and 1 month, 3 months and 6 months after patch application.
measure: Neuropathic pain evaluation for child with intellectual deficiency
timeFrame: Baseline, 3 months, 6 months and 1 month, 3 months and 6 months after patch application.
measure: Neuropathic pain description for child aged from 5 to 11 years
timeFrame: Baseline and 1 month, 3 months and 6 months after patch application.
measure: Neuropathic pain diagnostic for child aged from 5 to 11 years
timeFrame: Baseline and 1 month, 3 months and 6 months after patch application.
measure: Neuropathic pain evaluation for child aged from 5 to 11 years
timeFrame: Baseline, 3 months, 6 months and 1 month, 3 months and 6 months after patch application.
measure: Neuropathic pain description for child aged from 12 to 17 years
timeFrame: Baseline and 1 month, 3 months and 6 months after patch application.
measure: Neuropathic pain evaluation for child aged from 12 to 17 years
timeFrame: Baseline, 3 months, 6 months and 1 month, 3 months and 6 months after patch application.
measure: Neuropathic pain diagnostic for child aged from 12 to 17 years
timeFrame: Baseline and 1 month, 3 months and 6 months after patch application.
measure: Functional disability evaluation for child aged from 5 to 17 years
timeFrame: Baseline and 1 month, 3 months and 6 months after patch application.
measure: Pain description for child aged from 5 to 17 years : number of painful access
timeFrame: Baseline and 1 month, 3 months and 6 months after patch application.
measure: Pain description for child aged from 5 to 17 years : duration of painful access
timeFrame: Baseline and 1 month, 3 months and 6 months after patch application.
measure: Pain description for child aged from 5 to 17 years : trigger factor of the painful access
timeFrame: Baseline and 1 month, 3 months and 6 months after patch application.
measure: Pain description for child aged from 5 to 17 years : sensation
timeFrame: Baseline and 1 month, 3 months and 6 months after patch application.
measure: Pain description (observed signs) for child aged from 0 to 4 years or with intellectual deficiency
timeFrame: Baseline and 1 month, 3 months and 6 months after patch application.
measure: Pain description (sleep quality) for child aged from 0 to 4 years or with intellectual deficiency
timeFrame: Baseline and 1 month, 3 months and 6 months after patch application.
measure: Pain description (child behaviour) for child aged from 0 to 4 years or with intellectual deficiency
timeFrame: Baseline and 1 month, 3 months and 6 months after patch application.
measure: Tolerance assessment (duration of patch application)
timeFrame: Baseline, 3 months and 6 months
measure: Tolerance assessment (number of patch used)
timeFrame: Baseline, 3 months and 6 months
measure: Tolerance assessment (cutaneous state)
timeFrame: Baseline, 3 months and 6 months
measure: Tolerance assessment (skin aspect)
timeFrame: Baseline, 3 months and 6 months : 4, 8, 24, 48 and 72 hours after patch application
measure: Tolerance assessment (icing)
timeFrame: Baseline, 3 months and 6 months : 4, 8, 24, 48 and 72 hours after patch application
measure: Tolerance assessment (rescue medication)
timeFrame: Baseline, 3 months and 6 months : 4, 8, 24, 48 and 72 hours after patch application
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU d'Amiens
city: Angers
country: France
facility: CHU Angers
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Bourg-en-Bresse
country: France
facility: CHR Bourg en Bresse
city: Brest
country: France
facility: CHU de Brest
city: Caen
country: France
facility: CHU Caen
city: Grenoble
country: France
facility: CHU Grenoble
city: Lille
country: France
facility: CHU Lille
city: Limoges
country: France
facility: CHU Limoges
city: Lyon
country: France
facility: CHU Lyon
city: Marseille
country: France
facility: CHU Marseille
city: Montpellier
country: France
facility: CHU Montpellier
city: Nancy
country: France
facility: CHU Nancy
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: CHU Robert Debré
city: Paris
country: France
facility: CHU Trousseau
city: Rouen
country: France
facility: CHU Rouen
city: Strasbourg
country: France
facility: CHRU Strasbourg
city: Toulouse
country: France
facility: CHU Toulouse
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: CHRU of Brest
name: Philippe J Le Moine, MD
role: PRINCIPAL_INVESTIGATOR
References: