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

Chronic Pain Clinical Trial

— CAPSULE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05299294
• Other study ID #: 29BRC21.0184 (CAPSULE)
• Status: Recruiting
• Start date: May 12, 2022
• Est. completion date: September 12, 2027

Study information

• Verified date: May 2024
• Source: University Hospital, Brest
• Contact: Philippe J Le Moine, MD
• Phone: +33298223956
• Email: philippe.lemoine[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

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 (Less than 24 hours for 75%, 100% to 72 hours on unpublished personal series.)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

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 Expected duration is less than 24 Hours for 75% patients and 100 % at 72 Hours, from unpublished personal data.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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: September 12, 2027
• Est. primary completion date: May 12, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Neuralgia
• Neuropathic Pain

Intervention

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

Locations

Country	Name	City	State
France	CHU d'Amiens	Amiens
France	CHU Angers	Angers
France	CHU Bordeaux	Bordeaux
France	CHR Bourg en Bresse	Bourg-en-Bresse
France	CHU de Brest	Brest
France	CHU Caen	Caen
France	CHU Grenoble	Grenoble
France	CHU Lille	Lille
France	CHU Limoges	Limoges
France	CHU Lyon	Lyon
France	CHU Marseille	Marseille
France	CHU Montpellier	Montpellier
France	CHU Nancy	Nancy
France	CHU Nantes	Nantes
France	CHU Robert Debré	Paris
France	CHU Trousseau	Paris
France	CHU Rouen	Rouen
France	CHRU Strasbourg	Strasbourg
France	CHU Toulouse	Toulouse
France	Institut Gustave Roussy	Villejuif

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Brest	Fondation Apicil, Fondation de France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success or failure of pain treatment : Number of patients with success and number of patients with failure of treatment with capsaicin	The success is defined by the absence of use of pain medication during the three months after the end of capsaicin application protocol	3 months after last patch application
Secondary	Indication of capsaicin use	Indication for treatment with capsaicine will be collected (context of emergence of pain, descriptive data)	At recruitment visit
Secondary	Success or failure of pain treatment : Number of patients who use or not use antalgic and/or comfort medication (including for improving sleep)	Use of antalgic and/or comfort medication (including for improving sleep). Success is de fined by the non use of antalgic and/or comfort medication (including for improving sleep)	Baseline and 1 month, 3 months and 6 months after patch application.
Secondary	Neuropathic pain evaluation for child aged from 0 to 4 years	Score of HECP (Hetero-Evaluation of Child Pain) questionnaire, score from 0 to 10 (a higher score means a worse outcome)	Baseline, 3 months, 6 months and 1 month, 3 months and 6 months after patch application.
Secondary	Neuropathic pain evaluation for child with intellectual deficiency	Score of PAGID (Pain Assessment Grid - Intellectual Deficiency) or PPP (Pediatric Pain Profile) questionnaire, higher scores are worse outcome	Baseline, 3 months, 6 months and 1 month, 3 months and 6 months after patch application.
Secondary	Neuropathic pain description for child aged from 5 to 11 years	Global score and subscores of NPSI (Neuropathic Pain Syndrome Inventory), questionnaire with support, score from 0 to 100, higher score is worse outcome	Baseline and 1 month, 3 months and 6 months after patch application.
Secondary	Neuropathic pain diagnostic for child aged from 5 to 11 years	Global score of pPN4 (Paediatric Neuropathic Pain 4 points) questionnaire, score from 0 to 10, higher score is worse item	Baseline and 1 month, 3 months and 6 months after patch application.
Secondary	Neuropathic pain evaluation for child aged from 5 to 11 years	Score of pVAS (Paediatric Visual Analogic Scale) or NS (Numeric Scale) or Revised Faces Pain Scales, score from 0 to 10, higher score is worse outcome	Baseline, 3 months, 6 months and 1 month, 3 months and 6 months after patch application.
Secondary	Neuropathic pain description for child aged from 12 to 17 years	Global score and subscores of NPSI (Neuropathic Pain Syndrome Inventory) questionnaire without support, score from 0 to 100, higher score is worse outcome	Baseline and 1 month, 3 months and 6 months after patch application.
Secondary	Neuropathic pain evaluation for child aged from 12 to 17 years	Score of VAS (Visual Analogic Scale) or NS (Numeric Scale), score from 0 to 10, higher score is worse outcome	Baseline, 3 months, 6 months and 1 month, 3 months and 6 months after patch application.
Secondary	Neuropathic pain diagnostic for child aged from 12 to 17 years	Global score of NP4 questionnaire (Neuropathic Pain 4 points), score from 0 to 10, higher score is worse item	Baseline and 1 month, 3 months and 6 months after patch application.
Secondary	Functional disability evaluation for child aged from 5 to 17 years	Global score of FDI (Functional Disability Inventory) questionnaire, score from 0 to 60, higher score is worse outcome	Baseline and 1 month, 3 months and 6 months after patch application.
Secondary	Pain description for child aged from 5 to 17 years : number of painful access	Number of painful access (crisis) in one day	Baseline and 1 month, 3 months and 6 months after patch application.
Secondary	Pain description for child aged from 5 to 17 years : duration of painful access	Mean duration of painful access (crisis) in minutes	Baseline and 1 month, 3 months and 6 months after patch application.
Secondary	Pain description for child aged from 5 to 17 years : trigger factor of the painful access	Type of trigger factor that leads to the painful access	Baseline and 1 month, 3 months and 6 months after patch application.
Secondary	Pain description for child aged from 5 to 17 years : sensation	Description of sensation reported by the child (sensation spontaneously described, qualitative data)	Baseline and 1 month, 3 months and 6 months after patch application.
Secondary	Pain description (observed signs) for child aged from 0 to 4 years or with intellectual deficiency	Description of observed signs related to pain	Baseline and 1 month, 3 months and 6 months after patch application.
Secondary	Pain description (sleep quality) for child aged from 0 to 4 years or with intellectual deficiency	Description of sleep quality (night awakening / week)	Baseline and 1 month, 3 months and 6 months after patch application.
Secondary	Pain description (child behaviour) for child aged from 0 to 4 years or with intellectual deficiency	Description of child behaviour related to pain (antalgic position)	Baseline and 1 month, 3 months and 6 months after patch application.
Secondary	Tolerance assessment (duration of patch application)	Duration of patch application in minutes	Baseline, 3 months and 6 months
Secondary	Tolerance assessment (number of patch used)	Number of patch used during the application	Baseline, 3 months and 6 months
Secondary	Tolerance assessment (cutaneous state)	Cutaneous state (burning, erythema, healthy skin, other) just after patch removal	Baseline, 3 months and 6 months
Secondary	Tolerance assessment (skin aspect)	Local aspect of skin : presence of erythema Yes or No, in the hours and days following patch application	Baseline, 3 months and 6 months : 4, 8, 24, 48 and 72 hours after patch application
Secondary	Tolerance assessment (icing)	Need for icing (YES/NO) against pain	Baseline, 3 months and 6 months : 4, 8, 24, 48 and 72 hours after patch application
Secondary	Tolerance assessment (rescue medication)	Intake of rescue medication against pain (YES/NO)	Baseline, 3 months and 6 months : 4, 8, 24, 48 and 72 hours after patch application