To compare between intravenous Levetiracetam and Intravenous Phenytoin which is better as second Line anticonvulsant in paediatric status Epilepticus

Intravenous Levetiracetam versus Intravenous Phenytoin for Second line treatment of Pediatrics Convulsive Status Epilepticus - Open label Randomized Controlled Trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/12/029566

Enrollment

Registered

2020-12-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: G968- Other specified disorders of central nervous system

Interventions

Intervention1: Levetiracetam: Levetiracetam group will receive 40 mg/kg intravenously diluted with sodium chloride 0.9% in 1:1 ratio and give over 5 minutes . Control Intervention1: Phenytoin: Phenyto

Eligibility

Inclusion criteria

Inclusion criteria: 1. Presenting with generalized tonic clinic ,generalized clonic,generalized tonic,generalised myoclonic ,focal tonic or focal clonic seizures 2. Children who had received 2 doses of midazolam 3. Children who had received 2 doses of midazolam for generalized convulsive seizures lasting more than 5 minutes and continued to have persistent or recurrent convulsions in the emergency department at least 5 minutes after the last dose of benzodiazepines 4. Patient on maintenance dose of phenytoin and Levetiracetam with bad compliance

Exclusion criteria

Exclusion criteria: 1.Age 15 years of age . 2. Children presenting with absence seizures or infantile spasms . 3. Convulsive status Epilepticus due to hypocalcemia,hypoglycaemia,hypercalcemia . 4. Patient had received second line Anticonvulsant during the episode of convulsive status epilepticus . 5. Patients with arrhythmia . 6. Patients allergic to Levetiracetam and phenytoin . 7. Patients already on maintenance dose of phenytoin and Levetiracetam with good compliance . 8. Seizure controlled with 2 doses of midazolam . 9. Parents / care providers not giving consent .

Design outcomes

Primary

Measure	Time frame
Absence of clinically apparent seizures after 5 minutes of completion of trial drug infusion without additional anticonvulsants medication.Timepoint: 2 years	—

Secondary

Measure	Time frame
Patients requiring further anticonvulsants to manage convulsive status epilepticus,recurrence of seizures, change in cardio respiratory parameter ,need for admission to PICU and any drug related serious adverse reactions .Timepoint: 2 years	—

Countries

India

Contacts

Public ContactManas Ranjan Sahoo

AIIMS Raipur

mamumkartek47@gmail.com8098220235

Outcome results

None listed

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