Levetiracetam Versus Phenytoin in Management of Pediatric Status Epilepticus

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

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.

Study Overview

• Status: Unknown
• Conditions: Comparison; the Efficacy of Levetireacetam; Phenytoin; Management of Pediatric Status Epilepticus
• Intervention / Treatment: Drug: Levetiracetam Injection; Drug: Phenytoin Injection

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Gharbia
    • Tanta, Gharbia, Egypt, 3111
      • Recruiting
      • tanta university, faculty of medicine
      • Contact: Azza Kamal Al-shahawy, Professor of pediatrics; Email: azzaalshahawy@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Levetiracetam; 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; 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.; Other Names: levetiracetam
ACTIVE_COMPARATOR: Phenytoin; 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; 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.; Other Names: Phenytoin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Amira Darwish, MD, Tanta university hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ANTICIPATED): February 1, 2020
• Study Completion (ANTICIPATED): August 1, 2020

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (ACTUAL): November 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 25, 2019
• Last Update Submitted That Met QC Criteria: November 22, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: children; Phenytoin; status epilepticus; Levetireacetam
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures; Status Epilepticus; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Nootropic Agents; Levetiracetam; Phenytoin
• Other Study ID Numbers: TUjune2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No