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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Leon Berard
• Treatments: Lidocaine

Criteria

Inclusion Criteria:

• 6 years <= Age <= 21 years

• With:

• Pure or mixed, localized, superficial neuropathic pains for which the neuropathic pain score DN4 is greater than or equal to 4

• Or localized, superficial sickle cell crisis pains Insufficiently relieved by commonly used therapeutic (analgesic level II or III and / or antiepileptic drugs, and / or neuroleptics) - GCS > 12

• Covered by a medical insurance

• Signed written informed consent form(for minors unemancipated, permission will be given by holders of parental authority)

Exclusion Criteria:

• Clinical condition not permitting data reporting (impaired consciousness)

• Painful area with an surface greater than:

• 150 cm² for a patient with total body surface area < 1 m²

• 300 cm² for a patient with 1 m² < total body surface area < 1.5 m²

• 450 cm² for a patient with total body surface area > 1.5 m²

• Existence of a statement for the use of lidocaine 5% (VERSATIS® 5%) plaster as defined in the summary of product characteristics, as:

• known hypersensitivity to the active substance or excipients

• known hypersensitivity to other local anesthetics such as amide (eg bupivacaine, etidocaine, mepivacaine and prilocaine)

• inflammatory or injured skin (active lesions of herpes zoster, dermatitis or wounds)

• Severe cardiac insufficiency

• Severe renal insufficiency

• Severe hepatic insufficiency

• Patient receiving anti-arrhythmic class I or other local anesthetics.

• Pregnant or lactating female or female of child-bearing potential not employing adequate contraception

• Patient included in another clinical trial on the management of pain