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

Does intravenous (IV) levetiracetam or IV phenytoin terminate seizures better when used as a second line treatment for the emergency management of convulsive status epilepticus (CSE) in children.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000129583

Acronym

ConSEPT

Enrollment

200

Registered

2015-02-11

Start date

2015-02-13

Completion date

2018-01-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Aim: To determine whether intravenous (IV) levetiracetam or IV phenytoin is the better second line treatment for the emergency management of convulsive status epilepticus (CSE) in children. Design and Methods: A randomised controlled trial (RCT) comparing levetiracetam (40mg/kg, maximum 3g) with phenytoin (20mg/kg, maximum 1g) in 200 children, aged between 3 months and 16 years, presenting with CSE who are still seizing after two doses of benzodiazepines. The study will occur over three years in 13 Emergency Departments (EDs) in New Zealand and Australia associated with the Paediatric Research in Emergency Departments International Collaborative (PREDICT) research network. The primary outcome for the study is clinical cessation of seizure activity five minutes following infusion of the study drug. Secondary outcomes include; time to clinical cessation of seizure activity, need for intubation with rapid sequence induction (RSI)/intensive care unit (ICU) admission, serious adverse events, length of hospital stay, health utility, health costs, and long-term outcome.

Interventions

Single 40mg/kg IV levetiracetam infusion (maximum 3g) over 5 minutes

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

3 Months to 16 Years

Healthy volunteers

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.

Outcome results