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临床试验/CTRI/2021/03/032145
CTRI/2021/03/032145已完成未知

Early versus Late switch over of Antiepileptic drugs from Intravenous to the Oral route in children aged 1 month to 18 years with seizures: Single blinded, Randomized controlled trial - ELAIO trial

All India Institute of Medical Sciences0 个研究点目标入组 112 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
已完成
入组人数
112

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

  • 1. Children aged between 1 month-18 years, presented to paediatric emergency/ward/OPD with at least one episode of clinical seizure
  • 2. At least one episode of seizure during the hospital stay
  • 3. Requires at least one dose of intravenous antiepileptic drug
  • 4. Able to receive and tolerate medications via oral or gastric feeding tube route
  • 5. Able to receive and tolerate a diet or enteral feeding (via gastric feeding tube)

排除标准

  • 1. Clinical suspicion of Non Convulsive Status Epilepticus (Salzburg criteria), but EEG has not ruled out NCSE
  • 2. Refractory nausea, vomiting and/or diarrhea in the last24 hours
  • 3. Use of a feeding tube that terminates distal to the stomach (e.g. jejunal tube)
  • 4. Active gastrointestinal bleeding
  • 5. Any other physical condition, likely to increase risk of aspiration on oral ingestion, impair absorption, first-pass metabolism or bioavailability
  • 6. Caregiver not providing informed consent.

研究者

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