Levetiracetam Versus Phenytoin in Management of Pediatric Status Epilepticus

Tanta University

Status and phase: Unknown; Phase 4

Conditions: Comparison; Management of Pediatric Status Epilepticus; the Efficacy of Levetireacetam; Phenytoin

Treatments: Drug: Levetiracetam Injection; Drug: Phenytoin Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04176887

TUjune2018

Details and patient eligibility

About

The study will be conducted on 60 children suffering from status epilepticus who will be admitted to Pediatric Neurology Unit and Pediatric ICU of Tanta Hospital University.

Full description

The aim of this work is to compare the efficacy of Levetireacetam and Phenytoin in management of pediatric status epilepticus.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 days to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children suffering from convulsive generalized tonic clonic status epilepticus at any age.

Exclusion criteria

• Non convulsive status epilepticus.
• Children with known contraindication or allergy to levetireacetam or phenytoin.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Levetiracetam

Experimental group

Description:

The levetiracetam dose is 20- 40 mg/kg by intravenous infusion over 15 minute, a rate of 2-5 mg/kg/minute diluted in 100 ml with 0.9% sodium chloride as a single dose.

Treatment:

Drug: Levetiracetam Injection

Phenytoin

Active Comparator group

Description:

Phenytoin dose is 20-40 mg/kg/min by intravenous infusion over 30 minute, diluted with 0.9% sodium chloride to a maximum concentration of 10 mg/ml.

Treatment:

Drug: Phenytoin Injection