NCT01314300

Lidocaine 5% Plasters (Versatis® 5%) in Pediatric Neuropathic Pains and Vasoocclusive Sickle Cell Crisis Pains

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: All
• Age: 6 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Neuropathic Pains
• Vasoocclusive Sickle Cell Crises Pains

Interventions

Type	Name	Description
DRUG	Lidocaine	Lidocaine 5% plaster

Timeline

• Start date: 2011-03-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2011-03-14
• Last updated: 2014-10-30

Locations

2 sites across 1 country: France