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.
| Status | Completed |
| Enrollment | 39 |
| Est. completion date | July 2014 |
| Est. primary completion date | July 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 6 Years to 21 Years |
| Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Médico-chirurgical de Réadaptation des Massues | Lyon | |
| France | IHOP | Lyon |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Leon Berard |
France,
Garnock-Jones KP, Keating GM. Lidocaine 5% medicated plaster: a review of its use in postherpetic neuralgia. Drugs. 2009 Oct 22;69(15):2149-65. doi: 10.2165/11203220-000000000-00000. Review. — View Citation
Rowbotham MC, Davies PS, Verkempinck C, Galer BS. Lidocaine patch: double-blind controlled study of a new treatment method for post-herpetic neuralgia. Pain. 1996 Apr;65(1):39-44. — View Citation
Walco GA, Dworkin RH, Krane EJ, LeBel AA, Treede RD. Neuropathic pain in children: Special considerations. Mayo Clin Proc. 2010 Mar;85(3 Suppl):S33-41. doi: 10.4065/mcp.2009.0647. Review. — View Citation
Walker SM. Pain in children: recent advances and ongoing challenges. Br J Anaesth. 2008 Jul;101(1):101-10. doi: 10.1093/bja/aen097. Epub 2008 Apr 21. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Lidocaine 5% plaster efficacy between t0 and t12 | Rate of patients with a decrease of at least 2 points in pain score (at least 2 of 3 consecutive days) measured by self-assessment on a visual analogue scale (VAS) graded from 0 to 10 (0 = absence pain and 10 = maximal pain ), between start of treatment(t0) and a measure carried out 12 hours later (t12). | 12 hours | No |
| Secondary | Lidocaine 5% plaster efficacy between t0 and t6 | Rate of patients with a decrease of at least 2 points in pain score (at least 2 of 3 consecutive days) measured by self-assessment on a visual analogue scale (VAS) graded from 0 to 10 (0 = absence pain and 10 = maximal pain ), between start of treatment(t0) and a measure carried out 6 hours later (t6). | 6 hours | No |
| Secondary | Lidocaine 5% plaster safety | Rate of patients with local and/or general adverse event as graded using NCI-CTCAE V4.0 | 72 hours | Yes |