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
Enfermedades del sistema nervioso+5
+ Neuralgia
+ Manifestaciones Neurológicas
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de marzo de 2011
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 39 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 6 a 21 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 2 ubicaciones
Centre Médico-chirurgical de Réadaptation des Massues
Lyon, France