Emergency treatment with levetiracetam or phenytoin in status epilepticus

Phase 4

Completed

• Conditions: Status epilepticus; Nervous System Diseases

• Registration Number: ISRCTN22567894
• Lead Sponsor: niversity of Liverpool (UK) and Alder Hey Children's NHS Foundation Trust

Brief Summary

1. 2017 protocol in https://www.ncbi.nlm.nih.gov/pubmed/28629473 2. 2019 results in https://www.ncbi.nlm.nih.gov/pubmed/31005385 (added 23/04/2019) 3. 2020 results in https://pubmed.ncbi.nlm.nih.gov/33190679/ (added 17/11/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-27
• Study Completion: 2018-09-01
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified