Drugs for control of fits in children

Phase 4

Recruiting

• Conditions: status epilepticus in children

• Registration Number: CTRI/2017/07/008980
• Lead Sponsor: Government chengalpattu medical college

Brief Summary

This study is a randomised, open label  trial comparing levetiracetam as a second line drug in the place of fosphenytoin in status epilepticus among 170 children for 1 year  . Primary outcome is clinical cessation of seizure from the time of administration of the drug, Secondary outcome is seizure recurrence within 12 hours .

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2017-05-07
• Study Start: 2017-05-13

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

all consecutive children admitted with status epilepticus in PICU with seizures refractory to two doses of midazolam.

Exclusion Criteria

children who are loaded with drugs other than two doses of midazolam , pre-hospital therapy and with shock.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
clinical cessation of seizures	from the time of administration of the drug

Secondary Outcome Measures

Name	Time	Method
seizure recurrence within 12 hours	12 hours

Trial Locations

Locations (1)

chengalpattu medical college; 🇮🇳 Kancheepuram, TAMIL NADU, India

chengalpattu medical college

🇮🇳Kancheepuram, TAMIL NADU, India

Dr S Anupama

Principal investigator

9790823451

anups2k8mbbs@gmail.com