Comparitive Efficacy of IV Levetiracetam and IV Phenytoin in Acute Childhood Seizures

Completed

• Conditions: Acute Seizures

• Registration Number: CTRI/2014/01/004297
• Lead Sponsor: Kanika Singh

Brief Summary

**Rationale :**

IV levetiracetam has been shown to be safe and efficacious in treating adults and children with status epilepticus and acute repititve seizures.Growing evidence supports its use. This should now be confirmed with a randomised control trial.

**Objectives:**

1. To compare seizure control for 24 hours by Iv levetiracetam and IV phenytoin in acute childhood seizures.

2.To compare time for seizure control by IV levetiracetam and IV phenytoin.

3. To compare hemodynamic, cardiorespiratory changes and side effects in the two groups.

4. To measure drug levels of IV levetiracetam at 1 and 24 hrs and IV phenytoin at 4 and 24 hrs.

**Study Setting:**

The study will be conducted in the dept. of Paediatrics at UCMS and GTB Hospital, Delhi in collaboration with Dept of Neuropsychopharmacology at I.H.B.A.S, Delhi.

**Study Design:**

Randomised Control Trial

Participants :

100 children between 3-12 yrs of age presenting to paediatric emergency with acute seizures

Study Period:

November 2012 to April 2014

Methodology:

50 children will be given Iv levetiracetam and 50 children will be given IV phenytoin chosen by a computer generated random number table.

Statistical Analysis:

Chi square test will be used to compare all categorical variables, all quantitaive variables shall be compared by the unpaired t test. p value of less that 0.05 will be considered significant.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-16
• Last Update Posted: 2015-09-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. 2nd episode of GTCS 2) 1st episode partial seizure 3) not taking antiepileptic drugs for last 15days.

Exclusion Criteria

1. age <3yrs 2) pts with evidence of meningitis and sepsis 3) acute head trauma 4) febrile seizures 5) congenital anomalies and developmental delay 6) chronic liver disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Seizure control for next 24 hours	Seizure control for next 24 hours

Secondary Outcome Measures

Name	Time	Method
1)stopping of seizure within next 20mins	2)adverse effects

Trial Locations

Locations (1)

Paediatric Emergency ,Room no. 1104, Dept of Paediatrics, UCMS & GTB Hospital; 🇮🇳 East, DELHI, India

Paediatric Emergency ,Room no. 1104, Dept of Paediatrics, UCMS & GTB Hospital

🇮🇳East, DELHI, India

Kanika

Principal investigator

9899370793

kanika134@gmail.com