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

Recruiting

• Conditions: Paediatric Status Epilepticus; Neurological - Epilepsy

• Registration Number: ACTRN12615000129583
• Lead Sponsor: Starship Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

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.

Exclusion Criteria

1.Pregnancy;
2.Known contraindication or allergy to levetiracetam or phenytoin;
3.Major head injury;
4.Previous administration of second line anticonvulsants prior to ED arrival;
5.Current levetiracetam or phenytoin use;
6.Prior enrolment in the research;
7.Specific CSE management plan stating refractory to phenytoin.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[As study medications have different optimal infusion rates this will be 10 minutes after starting study infusions in the case of levetiracetam and 25 minutes after starting study infusions in the case of phenytoin. ]