Comparison of Efficacy of Phenytoin With Levetireacetam for the Management of Children With Status Epilepticus

ayesha tariq

Status and phase: Unknown; Phase 4

Conditions: Status Epilepticus

Treatments: Drug: intravenous levetireacetam

Study type: Interventional

Funder types: Other

Identifiers

NCT04829838

700/RC/KEMU

Details and patient eligibility

About

The purpose of studyis to compare the efficacy of phenytoin with levetiracetam for the management of children with status epilepticus.Study performa consists of demographic variables,exclusion criteria,history of epilepsy and efficacy achieved or not.

Full description

After getting informed consent 244 children with status epilepticus will be randomly classified into two groups.one group will receive levetireacetam and other group will be given phenytoin and their efficacy will be compared by observing them for breakthrough fits for next 48 hours.

Enrollment: 244 estimated patients

Sex: All

Ages: 2 months to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• childen of age less than 12 years either gender admitted in pediatric emergency with status epilepticus

Exclusion criteria

• children already taking either of trial drug or failed treatment with either of trial drug.children with comorbid conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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244 participants in 2 patient groups

Intravenous levetireacetam

Experimental group

Description:

Drug:Intravenous levetireacetam will be given at a loading dose of 20-30mg/kg then it will be added in maintainance dose of (5-30mg/kg/day)

Treatment:

Drug: intravenous levetireacetam

intravenous phenytoin

Experimental group

Description:

Intravenous phenytoin will be given in loading dose of 20mg/kg then it will be added in maintainance dose i-e 5-8mg/kg/day

Treatment:

Drug: intravenous levetireacetam