Actively Recruiting
Ketamine and Levetiracetam as Second-line Antiseizure Medication for Status Epilepticus in Children
Led by Sohag University · Updated on 2025-07-03
124
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
About 40% of children with generalized convulsive status epilepticus (GCSE) are not terminated by first-line benzodiazepines (BDZs), and approximately 50% of BDZ-refractory GCSE are not controlled by second-line antiseizure medications. This study investigates the efficacy of ketamine-levetiracetam combination vs. levetiracetam alone for treating children with BDZ-refractory GCSE.
CONDITIONS
Official Title
Ketamine and Levetiracetam as Second-line Antiseizure Medication for Status Epilepticus in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 1 year to 16 years
- Generalized convulsive status epilepticus (GCSE) with ongoing or repeated generalized tonic-clonic seizures lasting longer than 5 minutes
- Benzodiazepine-refractory GCSE defined as seizures continuing or recurring in the emergency room after adequate benzodiazepine dose given 5 to 30 minutes earlier
You will not qualify if you...
- Failure to obtain informed consent
- Prior treatment with antiseizure medications or anticonvulsant sedatives other than benzodiazepines for the current seizure episode
- Endotracheal intubation before enrollment
- Acute traumatic brain injury
- Cardiac arrest or post-anoxic seizures
- Hypoglycemia or hyperglycemia
- Known allergies or contraindications to ketamine or levetiracetam
- Failure to obtain intravenous access
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Pediatrics at Sohag University Hospital
Sohag, Egypt, 82524
Actively Recruiting
Research Team
E
Elsayed Abdelkreem, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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