Levetiracetam Versus Phenytoin in Management of Pediatric Status Epilepticus

Study Overview
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Brief Summary
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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.

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

Official Title
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Levetiracetam Versus Phenytoin in Management of Pediatric Status Epilepticus: a Randomized Clinical Trial

Conditions
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Comparison, the Efficacy of Levetireacetam, Phenytoin, Management of Pediatric Status Epilepticus

Intervention / Treatment
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* Drug: Levetiracetam Injection
* Drug: Phenytoin Injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Days
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levetiracetam<br>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. | Drug: Levetiracetam Injection<br>* 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.<br>* Other names: levetiracetam;|
| Active Comparator: Phenytoin<br>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. | Drug: Phenytoin Injection<br>* 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.<br>* Other names: Phenytoin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cessation of convulsion | seizure control based on stoppage of tonic and clonic movements and absence of epileptic activity in EEG | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bradycardia | monitoring of heart rate | 6 hours | 
| respiratory depression | monitoring of respiratory rate | 6 hours | 
| decreased conscious level | Glasgow Coma Score | 6 hours | 
| hypotension | measurement of blood pressure | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Levetireacetam, Phenytoin, status epilepticus, children