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Ketamine and Levetiracetam as Second-line Antiseizure Medication for Status Epilepticus in Children

RecruitingPhase 2, Phase 3Ages 1 Year - 16 YearsAllSohag University
NCT07046611 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age from 1 year to 16 years. * Generalized convulsive status epilepticus (GCSE), defined as clinically observed generalized tonic-clonic convulsions that continue or recur without complete regaining of consciousness in between for longer than 5 minutes. * Benzodiazepine-refractory, defined as continuous or recurrent GCSE in the emergency room after receiving an adequate benzodiazepine dose, with the last dose administered within 5 to 30 minutes. Exclusion Criteria: * Failure to obtain informed consent. * Prior treatment with antiseizure medication or anticonvulsant sedatives other than benzodiazepines for the presenting GCSE episode. * Endotracheal intubation before enrollment. * Acute traumatic brain injury. * Cardiac arrest/post-anoxic seizures * Hypoglycemia or hyperglycemia. * Known allergies or contraindications to ketamine or levetiracetam * Failure to obtain intravenous access.
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What it tests

  • Ketamine
  • Levetiracetam
  • Placebo
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Where

1 site
Department of Pediatrics at Sohag University Hospital
Sohag, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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