Actively Recruiting

Phase 2
Phase 3
Age: 1Year - 16Years
All Genders
NCT07046611

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

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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

Age: 1Year - 16Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Pediatrics at Sohag University Hospital

Sohag, Egypt, 82524

Actively Recruiting

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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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