Neuropathic Pains Clinical Trial
Official title:
VERSATIS - Efficacy and Safety of Lidocaine 5% Plasters (Versatis® 5%) in Child, Adolescents and Young Adults With Neuropathic Pains or Vasoocclusive Sickle Cell Crisis Pains
Lidocaine 5% plaster (VERSATIS® 5%) showed its efficacy and safety in the post-herpetic
zoster adult pains. This treatment is recommended in first intention in adult neuropathic
pains with allodynia.
The purpose of this study is to assess efficacy and safety of lidocaine 5% plaster
(VERSATIS® 5%) in the pediatric neuropathic pains and vasoocclusive sickle cell crises
pains.
Pediatric neuropathic pain are infrequent. It's difficult to estimate the prevalence. It may
result from several causes : infectious (post-herpetic neuropathy), traumatic (tumor or
Positional)or toxic (chemotherapy or radiotherapy). They are often associated with malignant
pediatric disease.
These pains are spontaneous, continuous or intermittent, as type of burns or electric shocks
or abnormal skin sensation (hyperesthesia or allodynia). Treatment is the same as in adults:
antiepileptic or neuroleptics, sometimes associated with analgesic (level 2 or 3).
Lidocaine 5% plaster are used in adults as first line of treatment to reduce post-herpetic
neuropathic pain, especially in cases of mechanical allodynia. These plasters are indicated
for the symptomatic treatment of post-herpetic neuropathic pain.
Each plaster contains 700 mg of lidocaine. It must be applied on the painful area once daily
for a maximum period of 12 hours per 24 hours.
The primary endpoint is to evaluate the efficacy of lidocaine 5% plaster (VERSATIS 5%) after
12 hours on reducing of pure or mixed neuropathic pain and on reducing of vasoocclusive
sickle cell pain, localized, superficial, in child, adolescent and young adult.
The secondary endpoint are:
1. to evaluate the efficacy of lidocaine 5% plaster (VERSATIS 5%) after 6 hours on
reducing of pure or mixed neuropathic pain and on reducing of vasoocclusive sickle cell
pain, localized, superficial, in child, adolescent and young adult.
2. to evaluate safety of lidocaine 5% plaster (VERSATIS® 5%) in these same indications.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment