Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children

Status Recruiting

Clinical Trial Summary

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).

Clinical Trial Description

Children aged to 12 to 17-years monitored in pediatric pain outpatient clinics in the designed investigation centers for a local chronic neuropathic pain lasting more than 2 months after trauma or surgery are proposed to participate the trial. Children with persistant neuropathic pain (DN4 (Diagnostic Neuropathic Pain) > or = 3/7 ou DN4 >or = 4/10) despite oral treatment following recommendations for neuropathic pain may be enrolled in the study. For children not very painful (NRS-11 (Numeric Rating Scale) < 7 and FDI (Functional Disability Inventory) < 30) and without any oral treatment for neuropathic pain, the study may be proposed as first line treatment. If both the child and his/her parents accept the trial, he/she will be included in the study. It is a multicentric randomized controlled superiority trial in parallel arms : - experimental arm: Capsaicin 8% cutaneous patch - controlled arm : Hydrocolloid dressing At M0, take place : baseline evaluation, agreement consent signature, inclusion and randomization, as well as first treatment application either capsaicin cutaneous patch or hydrocolloid dressing. , If needed, the treatment may be done twice with a second application three months later (M3). 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 4 months later (M4). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05997979
Study type	Interventional
Source	University Hospital, Brest
Contact	Philippe J LE MOINE, MD
Phone	+33298223956
Email	philippe.lemoine@chu-brest.fr
Status	Recruiting
Phase	Phase 2
Start date	March 5, 2024
Completion date	April 5, 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children — CAPSAPED

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms