A clinical trial to compare the efficacy of intravenous levetiracetam and intravenous phenytoin in control of convulsive status epileptics in children from age group one to twelve years

Efficacy of intravenous levetiracetam versus intravenous phenytoin in management of convulsive status epileptics in children; an open label randomised controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/01/022641

Enrollment

204

Registered

2020-01-07

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: G403- Generalized idiopathic epilepsy and epileptic syndromes

Interventions

Intervention1: Injection levetiracetam: Injection levetiracetam at the rate of 40 mg per kg per min (over 5 minutes) Control Intervention1: Injection phenytoin: Injection phenytoin at the rate of 20 m

Eligibility

Inclusion criteria

Inclusion criteria: All children from age of one year to 12 years presenting in status epilepticus not controlled by initial emergent therapy with benzodiazepines as per ILAE Protocol.

Exclusion criteria

Exclusion criteria: 1.Status epilepticus controlled by initial emergent therapy with benzodiazepines. 2.Children less than one year of age and >12 years Received loading dose of second-line anticonvulsants (Phenytoin, Phenobarbitone, Valproate, Levetiracetam) for control of current status epilepticus 3.History of Head injury. 4.Convulsions due to acute metabolic / electrolyte disturbances.

Design outcomes

Primary

Measure	Time frame
Intravenous levetiracetam is superior to intravenous phenytoin in control of convulsions in paediatric populationTimepoint: 24 months	—

Secondary

Measure	Time frame
To provide data regarding decrease incident of recurrence of convulsion while using intravenous levetiracetam in comparison to intravenous phenytoinTimepoint: 1 day	—

Countries

India

Contacts

Public ContactDr Trupti Gujarati

Government medical college and hospital Aurangabad

drtruptijoshi@gmail.com9823900642

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026