Efficacy Comparison Between Levetiracetam and Valproic Acid in Pediatric Patients With Status Epilepticus

Not Applicable

Completed

• Conditions: Status Epilepticus
• Interventions: Drug: Levetiracetam; Drug: Valproic acid

• Registration Number: NCT07052136
• Lead Sponsor: RESnTEC, Institute of Research

Brief Summary

Since there is a significant degree of variability in the results of previous studies and there exists a thirst for local data regarding this topic, the current study was planned, with the objective of comparing the efficacy of levetiracetam versus valproic acid in pediatric patients with status epilepticus.

Detailed Description

Early and sustained control of seizures is paramount in status epilepticus to save the life of the patient, and this warrants the use of the best drug based on evidence. Identifying a better drug in status epilepticus would add to the local data and help clinicians in making evidence-based decisions to opt for an appropriate treatment in case of failed response to benzodiazepines.

Study Timeline

• Study Start: 2024-11-01
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30
• Status Verified: 2025-06
• Study First Submitted: 2025-06-26
• Study First Submitted QC: 2025-06-26
• Last Update Submitted: 2025-06-26
• Study First Posted: 2025-07-04
• Last Update Posted: 2025-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

• Any gender
• Aged 2-14 years
• Presenting with status epilepticus

Exclusion Criteria

• Patients with focal seizures
• Patients already using valproic acid or levetiracetam
• Patients with a history of hypersensitivity to either drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levetiracetam group	Levetiracetam	In this group, patients were treated with intravenous levetiracetam (LEV) 20 mg/kg over 15 minutes, followed by 60 mg/kg/day in two divided doses over 24 hours.
Valproic acid group	Valproic acid	Patients received intravenous valproic acid at 15 mg/kg over 15 minutes, followed by 20 mg/kg/day in two divided doses over 24 hours.

Primary Outcome Measures

Name	Time	Method
Sustained control of seizure activity	24 hours	Sustained control was labeled when there was no seizure activity on EEG and regain of consciousness for ≥ 24 hours

Secondary Outcome Measures

Name	Time	Method
Immediate cessation of seizure activity	30 minutes	Immediate cessation was defined as cessation of seizure activity within 15-30 minutes, after completion of drug infusion.

Trial Locations

Locations (1)

Nishtar University Hospital; 🇵🇰 Multan, Punjab, Pakistan