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Levetiracetam Versus Sodium Valproate in Children With Refractory Generalized Convulsive Status Epilepticus

NCT02920060 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-09-30

No results posted yet for this study

Summary

This study is a randomized, open label, parallel group,comparing the safety and efficacy of valproate and levetiracetam in patients of age group 1 to 16 years with status epilepticus not responded to phenytoin and benzodiazepines approaching to pediatric emergency , IMS, BHU. The primary outcome measures will be Proportion of children in either group who have Cessation of all clinical seizure within 30 min of drug administration and secondary outcome will be time taken to control seizure (minutes) from the initiation of infusion. Proportion of children in either group who required additional drugs to abort ongoing clinical seizures, rates of adverse events (hypotension, bradycardia, respiratory depression, PICU stay, in hospital mortality) in the two groups were measured. Refractory status epilepticus condition is major pediatric neurological emergency with high mortality and morbidity. Till now, the treatment guidelines for it are based primarily on retrospective studies with very few randomized studies. There is lack of sufficient data to recommend one drug over another for treatment of refractory status epilepticus.

Conditions

  • Grand Mal Status Epilepticus

Interventions

DRUG

Intravenous levetiracetam

intravenous levetiracetam(30mg/kg bolus followed by 20mg/kg/dose IV 12 hourly).

DRUG

Sodium valproate

intravenous sodium valproate(20mg/kg bolus followed by 10 mg/kg/dose IV 8hrly)

Sponsors & Collaborators

  • Institute of Medical Sciences of the Banaras Hindu University, India

    collaborator OTHER

  • Banaras Hindu University

    lead OTHER

Principal Investigators

  • Rajniti Prasad, MD · Banaras Hindu University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-07-31
Completion
2016-08-31

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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 NCT02920060 on ClinicalTrials.gov