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Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children

ConditionsNeuropathic PainChronic Pain
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-17
SponsorUniversity Hospital, Brest

About this trial

This study concerns children aged to 12 to 17-years with local chronic neuropathic pain after trauma or surgery.

It is a multicentric randomized controlled superiority trial in parallel arms :

* experimental arm: Capsaicin 8% cutaneous patch * controlled arm : Hydrocolloid dressing

Treatment with capsaicin application is realized at baseline, and repeated 3 months after the first patch application if needed.

Tolerance is assessed during each application and by phone call in following days until stop of cold need.

Efficacy is assessed monthly by clinical consultation until the end of the study (month 4).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children aged 12 to 17 years (lower age limit of 12 has been chosen to ensure NPSI full filling).

Male or female.

Persistent neuropathic pain more than 3 months after surgery or trauma despite treatment following recommendations.

Neuropathic pain is defined as a DN4 score equal to or greater than 3/7 or 4/10, and localized in a nerve territory explained by the surgery or the trauma.

Disqualifiers

Intellectual deficiency not allowing full filling of NPSI.

Insufficient command of the French language to full fill NPSI and other evaluation tools.

Parents' refusal of consent.

Minor patients' opposition.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Capsaicin 8% patch

    Drug

    Patients will receive Capsaicin 8% patch at the inclusion of the study and three months later if it is necessary (persistant pain). Qutenza should be applied to intact, non-irritated, dry skin, and during 30 minutes for the feet or 60 minutes for other areas of the body.

  • Hydrocolloid dressing

    Device

    Patients will receive Hydrocolloid dressing at the inclusion of the study and three months later if it is necessary (persistant pain). Hydrocolloid dressing should be applied to intact, non-irritated, dry skin, and during 30 minutes for the feet or 60 minutes for other areas of the body.

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: QUTENZAActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The change in Neuropathic Pain Symptom Inventory score (NPSI)

The decrease in Neuropathic Pain Symptom Inventory score (NPSI) is evaluated before the first application (M0) of capsaicin or placebo and 4 months later (M4). NPSI (Neuropathic Pain Syndrome Inventory) is a questionnaire without support, score from 0 to 100, higher score is worse outcome.

Time frame
At baseline (day of the patch application) and 4 months after patch application

Secondary outcomes

1

Adverse event monitoring

Adverse event monitoring are collected during patch application and by phone calls in the following days.

Time frame
At day 0, day 1, day 2, day 3 after patch application
2

Vital signs

Cardiac frequency in Bpm

Time frame
At baseline, Month 1, Month 2, Month 3 and Month 4
3

Vital signs

Arterial pressure in mmHg

Time frame
At baseline, Month 1, Month 2, Month 3 and Month 4
4

Dermal assessment

Dermal assessment is evaluated with question concerning the treated area (YES/NO)

Time frame
At baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Brest

Lead sponsor

Source ClinicalTrials.gov
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