search
Back to results

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

Primary Purpose

Neuropathic Pains, Vasoocclusive Sickle Cell Crises Pains

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Lidocaine
Sponsored by
Centre Leon Berard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pains focused on measuring Child, adolescent, young adult, Plaster, Lidocaine

Eligibility Criteria

6 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IHOP
  • Centre Médico-chirurgical de Réadaptation des Massues

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Efficacy of Lidocaine 5% plaster

Arm Description

Treatment of pain by Lidocaine 5% plaster

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
Lidocaine 5% plaster safety
Rate of patients with local and/or general adverse event as graded using NCI-CTCAE V4.0

Full Information

First Posted
March 11, 2011
Last Updated
October 29, 2014
Sponsor
Centre Leon Berard
search

1. Study Identification

Unique Protocol Identification Number
NCT01314300
Brief Title
Lidocaine 5% Plasters (Versatis® 5%) in Pediatric Neuropathic Pains and Vasoocclusive Sickle Cell Crisis Pains
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Leon Berard

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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. to evaluate safety of lidocaine 5% plaster (VERSATIS® 5%) in these same indications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pains, Vasoocclusive Sickle Cell Crises Pains
Keywords
Child, adolescent, young adult, Plaster, Lidocaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Efficacy of Lidocaine 5% plaster
Arm Type
Experimental
Arm Description
Treatment of pain by Lidocaine 5% plaster
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
Versatis® 5%
Intervention Description
Lidocaine 5% plaster
Primary Outcome Measure Information:
Title
Lidocaine 5% plaster efficacy between t0 and t12
Description
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).
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Lidocaine 5% plaster efficacy between t0 and t6
Description
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).
Time Frame
6 hours
Title
Lidocaine 5% plaster safety
Description
Rate of patients with local and/or general adverse event as graded using NCI-CTCAE V4.0
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perrine MAREC-BERARD, M.D.
Organizational Affiliation
IHOP
Official's Role
Principal Investigator
Facility Information:
Facility Name
IHOP
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Centre Médico-chirurgical de Réadaptation des Massues
City
Lyon
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
18430745
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.
Results Reference
result
PubMed Identifier
20194147
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.
Results Reference
result
PubMed Identifier
19791831
Citation
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.
Results Reference
result
PubMed Identifier
8826488
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. doi: 10.1016/0304-3959(95)00146-8.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs