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

NCT07052136 — Not applicable, Completed, 138 participants, RESnTEC, Institute of Research

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

Registry	NCT07052136
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	138 (Actual)
Sponsor	RESnTEC, Institute of Research (Other)
Conditions	Status Epilepticus
Interventions	Levetiracetam, Valproic acid (Drug)
Dates	start 2024-11-01, primary completion 2025-04-30, completion 2025-04-30, first posted 2025-07-04, last updated 2025-07-04
Locations	1 site in Pakistan

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Levetiracetam group	Experimental	Drug: 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	Experimental	Drug: 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.

Levetiracetam (Drug): 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 (Drug): 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.

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 2 Years to 14 Years

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

+Locations (1)

Facility	City	Country	Status
Nishtar University Hospital	Multan, Punjab Province	Pakistan

+Investigators

Atifa Mazhar, Principal investigator, Nishtar University Hospital, Multan
Javaria Rasheed, FCPS, Study director, Nishtar University Hospital, Multan