Levetiracetam Versus Phenytoin in Management of Pediatric Status Epilepticus
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
September 11, 2019
CompletedFirst Posted
Study publicly available on registry
November 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedNovember 25, 2019
November 1, 2019
1.1 years
September 11, 2019
November 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cessation of convulsion
seizure control based on stoppage of tonic and clonic movements and absence of epileptic activity in EEG
30 minutes
Secondary Outcomes (4)
bradycardia
6 hours
respiratory depression
6 hours
decreased conscious level
6 hours
hypotension
6 hours
Study Arms (2)
Levetiracetam
EXPERIMENTALThe 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
ACTIVE COMPARATORPhenytoin 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Children suffering from convulsive generalized tonic clonic status epilepticus at any age.
You may not qualify if:
- Non convulsive status epilepticus.
- Children with known contraindication or allergy to levetireacetam or phenytoin.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Tanta University, Faculty of Medicine
Tanta, Gharbia Governorate, 3111, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amira Darwish, MD
Tanta University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of pediatrics and Principal Investigator
Study Record Dates
First Submitted
September 11, 2019
First Posted
November 25, 2019
Study Start
January 1, 2019
Primary Completion
February 1, 2020
Study Completion
August 1, 2020
Last Updated
November 25, 2019
Record last verified: 2019-11