Convulsive Status Epilepticus Paediatric Trial (ConSEPT): A PREDICT study comparing levetiracetam versus phenytoin for management of convulsive status epilepticus in children.

INTERVENTION: Single 40mg/kg IV levetiracetam infusion (maximum 3g) over 5 minutes CONDITION: Paediatric Status Epilepticus PRIMARY OUTCOME: Clinical cessation of seizure activity five minutes following the completion of the infusion of the study medication. This outcome will be assessed clinically by the treating team. This is a pragmatic end‐point and represents real life clinical practice as EEGs are not routinely available in emergency departments. The assessment of this outcome will be video recorded to allow for blinded confirmation of primary outcome by a panel of paediatric emergency physicians and paediatric neurologists blinded to treatment allocation. SECONDARY OUTCOME: Clinical cessation of seizure activity without the need for RSI or further seizure management (comparison of LP versus PL regimens) . Clinical cessation of seizure activity without the need for further seizure management after the initial agent (levetiracetam or phenytoin). Clinical seizure cessation. This outcome will be assessed clinically by the treating team. This is a pragmatic end‐point and represents real life clinical practice as EEGs are not routinely available in emergency departments. Death Health care costs based of diagnosis related group (DRG) costs from sites participating in the study. ICU admission Length of Hospital/ICU stay Need for RSI for on‐going seizure management Serious adverse events to be assessed clinically by treating team. Defined as: 1) Death; 2) Serious airway complications in the first 24 hours. Serious airway complications are defined as the “unexpected” use of an endotracheal tube; LMA; and surgical or needle cricothyrotomy. “Unexpected” is defined as the use of these interventions when it was not part of a planned RSI following failure of medical management, nor airway support required by a patient who develops a compromised airway secondary to seizure activity or first line CSE medications e.g. benzodiazepines; 3) Cardiovascular instability (cardiac arrest and arrhythmia requiring electrical cardioversion); 4) Any other event not mentioned above that is life‐threatening event or jeopardises the patient or requires medical or surgical intervention. ; INCLUSION CRITERIA: 1.Children aged between 3 months and 16 years; 2.CSE. CSE is defined clinically as a child who is unresponsive with continuing abnormality of movement (increased tone or jerking) of greater than five minutes duration, or two or more recurrent convulsions without recovery of conscious between convulsions, or three or more convulsions within the proceeding hour, and currently experiencing a convulsion. This definition encompasses the International League Against Epilepsy (ILAE) seizure types of generalised tonic‐clonic convulsions, secondarily generalised tonic‐clonic convulsions, and complex partial status epilepticus, but not absence, myoclonic, tonic and simple partial status epilepticus.