Comparison of Efficacy of Phenytoin With Levetireacetam for the Management of Children With Status Epilepticus

Phase 4

• Conditions: Status Epilepticus
• Interventions: Drug: intravenous levetireacetam

• Registration Number: NCT04829838
• Lead Sponsor: ayesha tariq

Brief Summary

The purpose of studyis to compare the efficacy of phenytoin with levetiracetam for the management of children with status epilepticus.Study performa consists of demographic variables,exclusion criteria,history of epilepsy and efficacy achieved or not.

Detailed Description

After getting informed consent 244 children with status epilepticus will be randomly classified into two groups.one group will receive levetireacetam and other group will be given phenytoin and their efficacy will be compared by observing them for breakthrough fits for next 48 hours.

Study Timeline

• Study Start: 2019-07-25
• Status Verified: 2021-03
• Study First Submitted: 2021-03-31
• Study First Submitted QC: 2021-03-31
• Last Update Submitted: 2021-03-31
• Study First Posted: 2021-04-02
• Last Update Posted: 2021-04-02
• Primary Completion: 2021-07-26
• Study Completion: 2021-07-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 244

Inclusion Criteria

• childen of age less than 12 years either gender admitted in pediatric emergency with status epilepticus

Exclusion Criteria

• children already taking either of trial drug or failed treatment with either of trial drug.children with comorbid conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Intravenous levetireacetam	intravenous levetireacetam	Drug:Intravenous levetireacetam will be given at a loading dose of 20-30mg/kg then it will be added in maintainance dose of (5-30mg/kg/day)
intravenous phenytoin	intravenous levetireacetam	Intravenous phenytoin will be given in loading dose of 20mg/kg then it will be added in maintainance dose i-e 5-8mg/kg/day

Primary Outcome Measures

Name	Time	Method
comparison of efficacy of levetireacetam with phenytoin for the management of children with status epilepticus	48 hours	the intervention will be considered efficacious if child will not have breakthrough fits for 48 hours

Trial Locations

Locations (1)

Ayesha Tariq; 🇵🇰 Lahore, Punjab, Pakistan