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To compare between intravenous Levetiracetam and Intravenous Phenytoin which is better as second Line anticonvulsant in paediatric status Epilepticus

Phase 4
Conditions
Health Condition 1: G968- Other specified disorders of central nervous system
Registration Number
CTRI/2020/12/029566
Lead Sponsor
Mamum Kartek
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Presenting with generalized tonic clinic ,generalized clonic,generalized tonic,generalised myoclonic ,focal tonic or focal clonic seizures

2. Children who had received 2 doses of midazolam

3. Children who had received 2 doses of midazolam for generalized convulsive seizures lasting more than 5 minutes and continued to have persistent or recurrent convulsions in the emergency department at least 5 minutes after the last dose of benzodiazepines

4. Patient on maintenance dose of phenytoin and Levetiracetam with bad compliance

Exclusion Criteria

1.Age <3 months and >15 years of age .

2. Children presenting with absence seizures or infantile spasms .

3. Convulsive status Epilepticus due to hypocalcemia,hypoglycaemia,hypercalcemia .

4. Patient had received second line Anticonvulsant during the episode of convulsive status epilepticus .

5. Patients with arrhythmia .

6. Patients allergic to Levetiracetam and phenytoin .

7. Patients already on maintenance dose of phenytoin and Levetiracetam with good compliance .

8. Seizure controlled with 2 doses of midazolam .

9. Parents / care providers not giving consent .

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Absence of clinically apparent seizures after 5 minutes of completion of trial drug infusion without additional anticonvulsants medication.Timepoint: 2 years
Secondary Outcome Measures
NameTimeMethod
Patients requiring further anticonvulsants to manage convulsive status epilepticus,recurrence of seizures, change in cardio respiratory parameter ,need for admission to PICU and any drug related serious adverse reactions .Timepoint: 2 years
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