Back to resultsLevetiracetam 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
About this trial
This is an interventional treatment trial for Comparison focused on measuring Levetireacetam, Phenytoin, status epilepticus, children
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.
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
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
Learn more about this trial
Levetiracetam Versus Phenytoin in Management of Pediatric Status Epilepticus
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