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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efficacy of Lidocaine 5% plaster | Experimental | Treatment of pain by Lidocaine 5% plaster |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Lidocaine 5% plaster |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
6 years <= Age <= 21 years
With:
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:
Existence of a statement for the use of lidocaine 5% (VERSATIS® 5%) plaster as defined in the summary of product characteristics, as:
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
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| Name | Affiliation | Role |
|---|---|---|
| Perrine MAREC-BERARD, M.D. | IHOP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IHOP | Lyon | 69008 | France | |||
| Centre Médico-chirurgical de Réadaptation des Massues |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18430745 | Result | 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. | |
| 20194147 | 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. |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Lidocaine 5% plaster safety | Rate of patients with local and/or general adverse event as graded using NCI-CTCAE V4.0 | 72 hours |
| Lyon |
| France |
| 19791831 | 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. |
| 8826488 | 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. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |