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Levetiracetam Versus Phenytoin in Management of Pediatric Status Epilepticus

Primary Purpose

Comparison, the Efficacy of Levetireacetam, Phenytoin

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Levetiracetam Injection
Phenytoin Injection
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Comparison focused on measuring Levetireacetam, Phenytoin, status epilepticus, children

Eligibility Criteria

30 Days - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Tanta University, Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Levetiracetam

Phenytoin

Arm 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.

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.

Outcomes

Primary Outcome Measures

cessation of convulsion
seizure control based on stoppage of tonic and clonic movements and absence of epileptic activity in EEG

Secondary Outcome Measures

bradycardia
monitoring of heart rate
respiratory depression
monitoring of respiratory rate
decreased conscious level
Glasgow Coma Score
hypotension
measurement of blood pressure

Full Information

First Posted
September 11, 2019
Last Updated
November 22, 2019
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT04176887
Brief Title
Levetiracetam Versus Phenytoin in Management of Pediatric Status Epilepticus
Official Title
Levetiracetam Versus Phenytoin in Management of Pediatric Status Epilepticus: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Anticipated)
Study Completion Date
August 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Comparison, the Efficacy of Levetireacetam, Phenytoin, Management of Pediatric Status Epilepticus
Keywords
Levetireacetam, Phenytoin, status epilepticus, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Levetiracetam
Arm Type
Experimental
Arm 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.
Arm Title
Phenytoin
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Levetiracetam Injection
Other Intervention Name(s)
levetiracetam
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Phenytoin Injection
Other Intervention Name(s)
Phenytoin
Intervention 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.
Primary Outcome Measure Information:
Title
cessation of convulsion
Description
seizure control based on stoppage of tonic and clonic movements and absence of epileptic activity in EEG
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
bradycardia
Description
monitoring of heart rate
Time Frame
6 hours
Title
respiratory depression
Description
monitoring of respiratory rate
Time Frame
6 hours
Title
decreased conscious level
Description
Glasgow Coma Score
Time Frame
6 hours
Title
hypotension
Description
measurement of blood pressure
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Days
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amira Darwish, MD
Phone
+1026380311
Email
amira.darwish@med.tanta.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amira Darwish, MD
Organizational Affiliation
Tanta University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tanta University, Faculty of Medicine
City
Tanta
State/Province
Gharbia
ZIP/Postal Code
3111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Azza Kamal Al-shahawy, Professor of pediatrics
Email
azzaalshahawy@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Levetiracetam Versus Phenytoin in Management of Pediatric Status Epilepticus

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