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

NCT ID: NCT01314300

Last Updated: 2014-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2014-07-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Efficacy of Lidocaine 5% plaster

Treatment of pain by Lidocaine 5% plaster

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

Lidocaine 5% plaster

Interventions

Lidocaine

Lidocaine 5% plaster

Intervention Type: DRUG

Other Intervention Names

Versatis® 5%

Eligibility 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Leon Berard

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Perrine MAREC-BERARD, M.D.

Role: PRINCIPAL_INVESTIGATOR

IHOP

Locations

IHOP

Lyon, , France

Centre Médico-chirurgical de Réadaptation des Massues

Lyon, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 18430745 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20194147 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19791831 (View on PubMed)

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.

Reference Type: RESULT

PMID: 8826488 (View on PubMed)

Other Identifiers

VERSATIS

Identifier Type: -

Identifier Source: org_study_id