Levetiracetam Versus Phenytoin in Management of Pediatric Status Epilepticus

Comparison Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04176887
• Other study ID #: TUjune2018
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: November 2019
• Source: Tanta University
• Contact: Amira Darwish, MD
• Phone: +1026380311
• Email: amira.darwish[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Comparison
• Management of Pediatric Status Epilepticus
• Phenytoin
• Status Epilepticus
• the Efficacy of Levetireacetam

Intervention

Drug:
• Levetiracetam Injection
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.
• Phenytoin Injection
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.

Locations

Country	Name	City	State
Egypt	Tanta University, Faculty of Medicine	Tanta	Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cessation of convulsion	seizure control based on stoppage of tonic and clonic movements and absence of epileptic activity in EEG	30 minutes
Secondary	bradycardia	monitoring of heart rate	6 hours
Secondary	respiratory depression	monitoring of respiratory rate	6 hours
Secondary	decreased conscious level	Glasgow Coma Score	6 hours
Secondary	hypotension	measurement of blood pressure	6 hours