ISRCTN22567894已完成4 期

Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children (EcLiPSE) – an open-label randomised controlled trial

niversity of Liverpool (UK) and Alder Hey Children's NHS Foundation Trust0 个研究点目标入组 286 人开始时间: 2014年8月27日最近更新: 2020年11月30日

适应症

试验速览

•1. Males and females aged 6 months to 18 years (<18th birthday)
•2. Presenting seizure is tonic-clonic, clonic or focal convulsive status epilepticus that requires second-line treatment to terminate the seizure
•Added 09/04/2015:
•3. Two doses of benzodiazepines administered in order to try and terminate the seizure
•Note 1: Patients receiving oral phenytoin or levetiracetam as part of their regular oral anti-epileptic drug regime are eligible for this trial.
•Note 2: If more than two doses of benzodiazepines are administered prior to admission to ED then these patients are still eligible for EcLiPSE.
•Note 3: A very small number of families will have rectal paraldehyde rather than a rectal or buccal benzodiazepine as their child’s first-line rescue medication. These patients are eligible for EcLiPSE.

•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 individual rescue (emergency) 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 rectal paraldehyde or another second-line antiepileptic drug prior to arrival in the emergency department
•Added 09/04/2015:
•6. Known to have previously been randomised into EcLiPSE

发起方

niversity of Liverpool (UK) and Alder Hey Children's NHS Foundation Trust