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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01314300
• Date of registration: 11/03/2011
• Prospective Registration: No
• Primary sponsor: Centre Leon Berard
• Public title: Lidocaine 5% Plasters (Versatis® 5%) in Pediatric Neuropathic Pains and Vasoocclusive Sickle Cell Crisis Pains
• Scientific 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
• Date of first enrolment: March 2011
• Target sample size: 39
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01314300
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Perrine MAREC-BERARD, M.D.
• Affiliation: IHOP

Key inclusion & exclusion 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



Age minimum: 6 Years
Age maximum: 21 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Neuropathic Pains

Vasoocclusive Sickle Cell Crises Pains

Intervention(s)

Drug: Lidocaine

Primary Outcome(s)

Lidocaine 5% plaster efficacy between t0 and t12 [Time Frame: 12 hours]

Secondary Outcome(s)

Lidocaine 5% plaster efficacy between t0 and t6 [Time Frame: 6 hours]

Lidocaine 5% plaster safety [Time Frame: 72 hours]

Secondary ID(s)

VERSATIS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors