Emergency treatment with levetiracetam or phenytoin in status epilepticus

Conditions

Status epilepticus Nervous System Diseases Status epilepticus

Richard Appleton, Naomi Rainford, Carrol Gamble, Shrouk Messahel, Amy Humphreys et al. (16 authors)

Health Technology Assessment2020-11-0120 citations

Levetiracetam versus phenytoin for second-line treatment of paediatric convulsive status epilepticus (EcLiPSE): a multicentre, open-label, randomised trial.

Lyttle MD, Rainford NEA, Gamble C, Messahel S, Humphreys A, Hickey H, Woolfall K, Roper L, Noblet J, Lee ED, Potter S, Tate P, Iyer A, Evans V, Appleton RE, Paediatric Emergency Research in the United Kingdom & Ireland (PERUKI) collaborative.

2019-04-17155 citations

10.1016/s0140-6736(19)30724-x

Emergency treatment with levetiracetam or phenytoin in status epilepticus in children—the EcLiPSE study: study protocol for a randomised controlled trial

Mark D Lyttle, Carrol Gamble, Shrouk Messahel, Helen Hickey, Anand Iyer et al. (13 authors)

Trials2017-06-1931 citations

10.1186/s13063-017-2010-8

FIRST-line support for Assistance in Breathing in Children (FIRST-ABC): protocol for a multicentre randomised feasibility trial of non-invasive respiratory support in critically ill children

Padmanabhan Ramnarayan, Paula Lister, Troy E. Dominguez, Parviz Habibi, Naomi Edmonds et al. (8 authors)

BMJ Open2017-06-0115 citations

10.1136/bmjopen-2017-016181

Interventions

Eligible children will be randomised to receive either intravenous Levetiracetam 40 mg/kg administered as an infusion over 5 minutes or intravenous Phenytoin 20 mg/kg administered as an infusion over

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Time to cessation of all visible signs of convulsive seizure activity	—

Secondary

Measure	Time frame
1. Need for further anticonvulsant(s) to manage the seizure after the initial agent 2. Need for rapid sequence induction (RSI) with thiopentone or another agent (e.g. propofol) due to ongoing CSE 3. Need to be admitted to critical care 4. Serious adverse reactions including death, airway complications, and cardiovascular instability (cardiac arrest, arrhythmia and hypotension requiring intervention), extravasation injury ('purple-glove syndrome'), extreme agitation	—

Measure

Time frame

1. Need for further anticonvulsant(s) to manage the seizure after the initial agent 2. Need for rapid sequence induction (RSI) with thiopentone or another agent (e.g. propofol) due to ongoing CSE 3. Need to be admitted to critical care 4. Serious adverse reactions including death, airway complications, and cardiovascular instability (cardiac arrest, arrhythmia and hypotension requiring intervention), extravasation injury ('purple-glove syndrome'), extreme agitation

—

Countries

United Kingdom

Outcome results

None listed