A clinical trial to compare the efficacy of intravenous levetiracetam and intravenous phenytoin in control of convulsive status epileptics in children from age group one to twelve years

Phase 4

Completed

Conditions: Generalized idiopathic epilepsy and epileptic syndromes,

Registration Number: CTRI/2020/01/022641

Lead Sponsor: Dr Pooja Shankar Sawlani

Brief Summary: This study is an open labelled randomised controlled trial to compare efficacy of intravenous levetiracetam 40 mg per kg per min and intravenous phenytoin 20 mg per kg per min in management of convulsive status epileptics in children. The outcome of the study it to provide data that intravenous levetiracetam is superior to intravenous phenytoin.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 204

Inclusion Criteria

All children from age of one year to 12 years presenting in status epilepticus not controlled by initial emergent therapy with benzodiazepines as per ILAE Protocol.

Exclusion Criteria

1.Status epilepticus controlled by initial emergent therapy with benzodiazepines.
2.Children less than one year of age and >12 years Received loading dose of second-line anticonvulsants (Phenytoin, Phenobarbitone, Valproate, Levetiracetam) for control of current status epilepticus 3.History of Head injury.
4.Convulsions due to acute metabolic / electrolyte disturbances.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intravenous levetiracetam is superior to intravenous phenytoin in control of convulsions in paediatric population	24 months

Secondary Outcome Measures

Name	Time	Method
To provide data regarding decrease incident of recurrence of convulsion while using intravenous levetiracetam in comparison to intravenous phenytoin	1 day

Trial Locations

Locations (1): Paediatrics ward
🇮🇳
Aurangabad, MAHARASHTRA, India
Paediatrics ward
🇮🇳Aurangabad, MAHARASHTRA, India
Dr Pooja Shankar Sawlani
Principal investigator
7875016662
poojasaw17@gmail.com