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临床试验/NCT04287361
NCT04287361已完成不适用

Efficacy of Intravenous Clonazepam According to the Dosage in Children Status Epilepticus

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 310 人开始时间: 2019年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
310
试验地点
1
主要终点
effectiveness in stopping seizures

研究概览

简要总结

•Background: Intravenous clonazepam is the most widely used first-line benzodiazepine in Europe for the initial management of status epilepticus in children.

The guidelines of the "Société de reanimation de langue francaise" (SRLF) and the "société française de médecine d'urgence" (SFMU) published in 2018 recommend an initial loading dose of 0.015 mg / kg of clonazepam in this situation (maximum 1.5 mg).

To our knowledge, there is no specific study of the efficacy of clonazepam according to the dose used.

Objective: To compare the effectiveness of the initial loading dose of clonazepam in children treated for status epilepticus

•Methods: Monocentric retrospective study including children < 16 years who have benefited from an initial loading dose of clonazepam in the context of status epilepticus treated at the Montpellier University Hospital between January 2016 and June 2019.

The investigators collected data from medical records (clinic, treatment , evolution) and compared these according to the dosage of clonazepam used.

•Discussion: Among the benzodiazepines used in the first-line treatment of pediatric status epileptic, lorazepam and midazolam are the most widely used drugs in the world.

Lorazepam is not so much used in Europe because the injectable form is not available for a daily use. Conversely, clonazepam is used in a large number of European countries but is rarely used in the United States due to the lack of an injectable form.

About the tolerance of treatment, except overdose situations, clonazepam is a drug well tolerated in the pediatric populatin. The main side effects of clonazepam are respiratory depression and impaired alertness.

To our knowledge, this study is the first to examine the efficacy depending on the initial loading dosage of clonazepam in children status epilepticus.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
— 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

effectiveness in stopping seizures

时间窗: 1 day

The primary endpoint was clinical cessation of seizures, which was defined as the absence of clinical signs of seizures immediately following the injection of clonazepam.

次要结局

  • whether or not to use a dose greater than one milligram(1 day)
  • aetiologies ;(1 day)
  • using another antiepileptic drug(1 day)
  • Hospitalization in an intensive care or resuscitation unit(1 day)
  • need for a second dose of clonazepam(1 day)
  • duration of seizure(1 day)
  • type of seizures(1 day)
  • pre-hospital treatment used(1 day)
  • introduction of a maintenance dose(1 day)
  • Rate of hospitalization in conventional sector(1 day)
  • introduction of antiepileptic treatment after treatment(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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