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NCT04829838 Clinical Trial

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

Status Epilepticus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04829838
Other study ID # 700/RC/KEMU
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date July 25, 2019
Est. completion date July 26, 2021

Study information
Verified date March 2021
Source King Edward Medical University
Contact ayesha tariq, MBBS
Phone 0923360495413
Email docayesha86@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 244
Est. completion date July 26, 2021
Est. primary completion date July 26, 2021
Accepts healthy volunteers No
Gender All
Age group 2 Months to 12 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• intravenous levetireacetam
phenytoin is considered as control drug in the study

Locations
Country Name City State
Pakistan Ayesha Tariq Lahore Punjab

Sponsors (2)
Lead Sponsor Collaborator
ayesha tariq King Edward Medical University

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

Abend NS, Loddenkemper T. Pediatric status epilepticus management. Curr Opin Pediatr. 2014 Dec;26(6):668-74. doi: 10.1097/MOP.0000000000000154. Review. — View Citation

Smith DM, McGinnis EL, Walleigh DJ, Abend NS. Management of Status Epilepticus in Children. J Clin Med. 2016 Apr 13;5(4). pii: E47. doi: 10.3390/jcm5040047. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary comparison of efficacy of levetireacetam with phenytoin for the management of children with status epilepticus the intervention will be considered efficacious if child will not have breakthrough fits for 48 hours 48 hours
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