Emergency Treatment with Levetiracetam or Phenytoin in Status Epilepticus in Children (EcLiPSE) – an open label randomised controlled trial - EcLiPSE Version 1.0

niversity of Liverpool0 个研究点目标入组 286 人开始时间: 2015年1月20日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

•1. Males and females aged 6 months to 18 years (<18th birthday).
•2. Presenting seizure is generalised tonic-clonic, generalised clonic or focal clonic status epilepticus that requires second-line treatment to terminate the seizure.
•3. First-line treatment administered according to APLS guidelines or the child’s personalised rescue care plan in order to try and terminate the presenting seizure.
•Eligibility Notes
•APLS guidelines:
•Guidelines classify two doses of benzodiazepines as first-line treatment. If patients are given more than two doses of benzodiazepines then they are still eligible.
•Personalised rescue care plan:
•Patients whose personalised rescue care plan includes rectal paraldehyde as the first-line treatment are still eligible.
•Maintenance anti-epileptic medication:
•Patients receiving oral phenytoin or levetiracetam as part of their regular oral anti-epileptic drug regime are still eligible for this trial.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 308
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•1. Absence, myoclonic or non-convulsive status epilepticus, or infantile spasms.
•2. Known or suspected pregnancy.
•3. Known contra-indication or allergy to levetiracetam or phenytoin. This includes where the child’s personalised rescue care plan states that the child never responds to, or has previously experienced a severe adverse reaction to, phenytoin, levetiracetam, or both.
•4. Known renal failure (patients on peritoneal or haemodialysis or with renal function <50% expected for age)
•5. Previous administration of a second-line antiepileptic drug prior to arrival in the emergency department.
•6. Known to have previously been treated as part of EcLiPSE.

发起方

niversity of Liverpool