Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children
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
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
Treatments tested in this trial
- Capsaicin 8% patch
- Hydrocolloid dressing
Treatment groups
46 Participants
are divided into 2 treatment groupsLocations
10CHU d'Amiens Amiens France
CHU d'Angers Angers France
CHU de Bordeaux Bordeaux France
CHU de Brest Brest France
Sponsors and collaborators
University Hospital, Brest
Lead sponsor
Source ClinicalTrials.gov