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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04829838
Enrollment
244
Registered
2021-04-02
Start date
2019-07-25
Completion date
2021-07-26
Last updated
2021-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Status Epilepticus

Keywords

status epilepticus, children, phenytoin, levetireacetam

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.

Interventions

DRUGintravenous levetireacetam

phenytoin is considered as control drug in the study

Sponsors

King Edward Medical University
CollaboratorOTHER
ayesha tariq
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
2 Months to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
comparison of efficacy of levetireacetam with phenytoin for the management of children with status epilepticus48 hoursthe intervention will be considered efficacious if child will not have breakthrough fits for 48 hours

Countries

Pakistan

Contacts

Primary Contactayesha tariq, MBBS
docayesha86@gmail.com0923360495413
Backup Contactmohammad Haroon Hamid, MBBS,FCPS
PROFHAROON@KEMU.EDU.PK0923008880916

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026