MedPath

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

Phase 4
Completed
Conditions
Health Condition 1: G403- Generalized idiopathic epilepsy and epileptic syndromes
Registration Number
CTRI/2020/01/022641
Lead Sponsor
Dr Pooja Shankar Sawlani
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
106
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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Intravenous levetiracetam is superior to intravenous phenytoin in control of convulsions in paediatric populationTimepoint: 24 months
Secondary Outcome Measures
NameTimeMethod
To provide data regarding decrease incident of recurrence of convulsion while using intravenous levetiracetam in comparison to intravenous phenytoinTimepoint: 1 day
© Copyright 2025. All Rights Reserved by MedPath