Clinical trial

Efficacy of Phenytoin vs Levetiracetam in Status Epilepticus at Institute of Child Health,Faisalabad

Name
184-86
Description
Status epilepticus is the second most common neurologic emergency in children. Morbidity and mortality are considerable; thus, timely termination of convulsive status epilepticus is the primary goal of management to avoid these risks Our objective was to compare the efficacy of phenytoin and Levetiracetam in status epilepticus in children. This study was done in the pediatric emergency department of Children Hospital Faisalabad. A total of 70 patients were randomly allocated to one of the groups by a computer-generated random number table according to their admission in an emergency. Children in group A were given levetiracetam. Children in group B were given I/V phenytoin. For both groups if seizures recurred after the first loading dose an additional 10mg/kg of the same drug was given over 10 minutes. The patients were monitored to see whether there was any recurrence of seizure activity in the subsequent 24 hours. Seizure control was defined as the absence of seizure within 24 hours after the initial loading of the drug.
Trial arms
Trial start
2022-08-01
Estimated PCD
2023-01-31
Trial end
2023-01-31
Status
Completed
Treatment
Levetiracetam
Efficacy in fits
Arms:
levetiracetam
Phenytoin
Efficacy in fits
Arms:
phenytoin
Size
70
Primary endpoint
To compare the efficacy of phenytoin and Levetiracetam in status epilepticus in children.
Six months whole data was collected who were coming in the emergency department
To compare the efficacy of phenytoin and Levetiracetam in status epilepticus in children.
Six months
Eligibility criteria
Inclusion Criteria * Children with status Epilepticus i.e with continuous seizure of 5 min or more or two or more discrete seizures in which there is incomplete recovery of consciousness was included in this study. * Convulsive states epilepticus, * Generalized tonic clonic seizures, * Focal tonic clonic seizures are included. * Age:6 months to 12 years. * Gender: Both genders. Exclusion Criteria: * Participants on any antiepileptic drug (AED) or having allergic reaction towards phenytoin or Levetiracetam were excluded from the study. * Non convulsive status epilepticus, * Absence status epilepticus, * Myoclonic status epilepticus were excluded.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 70, 'type': 'ACTUAL'}}
Updated at
2023-10-04

1 organization

2 products

1 indication

Product
Phenytoin