Efficacy of Phenytoin vs Levetiracetam in Status Epilepticus at Institute of Child Health,Faisalabad
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- To compare the efficacy of phenytoin and Levetiracetam in status epilepticus in children.
Study Overview
Brief Summary
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.
Detailed Description
OPERATIONAL DEFINITION
Status Epilepticus:
It is defined as continuous seizure activity or recurrent seizure activity without regaining of consciousness lasting for more than 5 minutes.
Efficacy:
Efficacy means control of seizures without supplemental aid of either medication or no recurrence with in twenty-four hours.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 6 Months to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
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.
Arms & Interventions
levetiracetam
levetiracetam at a dose of 30 mg/kg diluted in 50 ml of normal saline in 15 minutes followed by a maintenance dose of 30mg/kg/day divided in two doses 12 hours apart after initial loading dose.
if seizures recurred after the first loading dose an additional 10mg/kg of the same drug was given over 10 minutes. If seizures recurred, the patients were loaded with sodium valporate 30 mg/kg diluted in 50 ml normal saline in 15 minutes.
Intervention: Levetiracetam (Drug)
phenytoin
I/V phenytoin at 20 mg/kg diluted in 50ml normal saline in 15 minutes followed by maintenance dose of 5 mg/kg/day divided in two doses 12 hours apart.
if seizures recurred after the first loading dose an additional 10mg/kg of the same drug was given over 10 minutes. If seizures recurred, the patients were loaded with sodium valporate 30 mg/kg diluted in 50 ml normal saline in 15 minutes.
Intervention: Phenytoin (Drug)
Outcomes
Primary Outcomes
To compare the efficacy of phenytoin and Levetiracetam in status epilepticus in children.
Time Frame: Six months
Others parameters which include level of consciousness (GCS), heart rate in Bpm, respiratory rate per minute, blood pressure with sphygnomanometer and oxygen saturation with pulse oximeter was noted first at the time of admission and then again at 30 minutes, 1hour, 6hour, 12hour and 24 hours.
Secondary Outcomes
No secondary outcomes reported
Investigators
Ali Raza Chaudhry
Senior Registrar Paediatric Surgery
Rawalpindi Medical College