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RecruitingPhase 2Phase 3NCT07046611

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

Efficacy of Combined Ketamine and Levetiracetam as a Second-line Anti-seizure Medication for Generalized Convulsive Status Epilepticus in Children

Sponsor

Sohag University

Enrollment

124 participants

Start Date

Jul 2, 2025

Study Type

INTERVENTIONAL

Conditions

Generalized Convulsive Status Epilepticus

Summary

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.

Eligibility

Min Age: 1 YearMax Age: 16 Years

Inclusion Criteria3

  • 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 Criteria8

  • 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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Interventions

DRUGKetamine

Intravenous ketamine (5 mg/ml concentration) 2 mg/kg (max 90 mg) over 2 minutes

DRUGLevetiracetam

Intravenous levetiracetam (50 mg/ml concentration) 60 mg/kg (max 4500 mg) over 5 minutes

DRUGPlacebo

Intravenous isotonic saline 0.4 mL/kg (maximum 18 mL) over 2 minutes

Locations(1)

Department of Pediatrics at Sohag University Hospital

Sohag, Egypt

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NCT07046611