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

NCT07046611 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2025-07-03

No results posted yet for this study

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.

Conditions

  • Generalized Convulsive Status Epilepticus

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

Sponsors & Collaborators

  • Sohag University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-02
Primary Completion
2026-06-30
Completion
2026-07-01

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07046611 on ClinicalTrials.gov