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

NCT01314300 | Completed Phase 2

• 1 other identifier: VERSATIS
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Neuropathic Pains; Vasoocclusive Sickle Cell Crises Pains

Keywords

Child, adolescent, young adult; Plaster; Lidocaine

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Lidocaine 5% plaster efficacy between t0 and t6

  6 hours

• Lidocaine 5% plaster safety

  72 hours

Study Arms (1)

Efficacy of Lidocaine 5% plaster

EXPERIMENTAL

Treatment of pain by Lidocaine 5% plaster

Drug: Lidocaine

Interventions

Lidocaine DRUG

Lidocaine 5% plaster

Also known as: Versatis® 5%

Efficacy of Lidocaine 5% plaster

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Clinical condition not permitting data reporting (impaired consciousness)
• Painful area with an surface greater than:
• cm² for a patient with total body surface area \< 1 m²
• cm² for a patient with 1 m² \< total body surface area \< 1.5 m²
• 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

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (2)

IHOP

Lyon, 69008, France

Location

Centre Médico-chirurgical de Réadaptation des Massues

Lyon, France

Location

Related Publications (4)

• 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.

  PMID: 18430745 RESULT

• 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.

  PMID: 20194147 RESULT

• 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.

  PMID: 19791831 RESULT

• 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. doi: 10.1016/0304-3959(95)00146-8.

  PMID: 8826488 RESULT

MeSH Terms

Conditions

Neuralgia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Perrine MAREC-BERARD, M.D.

  IHOP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2011
• First Posted: March 14, 2011
• Study Start: March 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 30, 2014

Record last verified: 2014-10

Locations

FR (2)