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临床试验/CTRI/2013/11/004178
CTRI/2013/11/004178Other4 期

Comparing the efficacy of intravenous Levetiracetam versus intravenous Valproate in the management of refractory status epilepticus in children : a randomised trial

pgimer0 个研究点目标入组 80 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
Other
发起方
pgimer
入组人数
80

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • Children aged 2 to 12 years old of either sex with ongoing clinical seizures(clonic, tonic, tonic clonic, myoclonic, focal or generalized)
  • Clinical seizures despite use of one or more doses of benzodiazepines (IV, IN, Buccal) and IV Phenytoin of 30 mg/kg or includes those who respond to initial doses (30 mg/kg ) of phenytoin but have recurrence within 6 hours of drug administration

排除标准

  • Non-convulsive status epilepticus
  • . Known or suspected cases of neurometabolic or mitochondrial disorders
  • Acute or chronic liver or kidney disease
  • Head injury or neurosurgery in the past one month.
  • Active or recent hemorrhage from any site
  • Documented platelet count <50,000, or INR >2
  • Known or suspected allergy or intolerance to either valproate or levetiracetam
  • Patients of epilepsy already on LEV( >20mg/kg/day) or VPA( >20mg/kg/day)

研究者

发起方
pgimer

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