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RECRUITING
NCT07046611
PHASE2/PHASE3

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

Sponsor: Sohag University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

1 Year - 16 Years

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2025-07-02

Completion Date

2026-07-01

Last Updated

2025-07-03

Healthy Volunteers

No

Interventions

DRUG

Ketamine

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

DRUG

Levetiracetam

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

DRUG

Placebo

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

Locations (1)

Department of Pediatrics at Sohag University Hospital

Sohag, Egypt