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

NCT06067412 | Completed DMC

• 1 other identifier: 184-86
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Status Epilepticus

Keywords

Efficacy; Phenytoin; Levetiracetam

Outcome Measures

Primary Outcomes (2)

• To compare the efficacy of phenytoin and Levetiracetam in status epilepticus in children.

  The patients were monitored to see whether there was any recurrence of seizure activity in subsequent 24 hours. Seizure control was defined as the absence of seizure for 24 hours after the initial loading of the drug.

  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.

  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.

  Six months

Study Arms (2)

levetiracetam

ACTIVE COMPARATOR

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.

Drug: Levetiracetam

phenytoin

ACTIVE COMPARATOR

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.

Drug: Phenytoin

Interventions

Levetiracetam DRUG

Efficacy in fits

levetiracetam

Phenytoin DRUG

Efficacy in fits

phenytoin

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaheed Zulfiqar Ali Bhutto Medical University: lead

Study Sites (1)

Children Hopsital Faisalabad

Faisalābad, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Status Epilepticus

Interventions

Levetiracetam; Phenytoin

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydantoins; Imidazolidines; Imidazoles; Azoles

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Registrar Paediatric Surgery

Study Record Dates

• First Submitted: September 10, 2023
• First Posted: October 4, 2023
• Study Start: August 1, 2022
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: October 4, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)