A Study Comparing Intravenous Levetiracetam and Phenobarbital for Treating Prolonged Seizures in Children Unresponsive to Benzodiazepines

What this Trial Is About

This research aims to compare the effects of intravenous levetiracetam and intravenous phenobarbital in children aged 1 month to 12 years who experience prolonged seizures that do not respond to two doses of benzodiazepines. Prolonged seizures can cause serious brain damage, and while benzodiazepines are commonly used first, many children do not respond to them. The study seeks to find which second-line medication is safer and more effective to help guide treatment choices for prolonged seizures in children in Myanmar. Children who qualify will be randomly assigned to receive either intravenous levetiracetam at 40 mgkg up to 3000 mg over 15 minutes or intravenous phenobarbital at 20 mgkg up to 1000 mg over 20 minutes. Both drugs are diluted with dextrose water before infusion. After the initial dose, if seizures stop, a maintenance dose of the assigned medication is given regularlylevetiracetam twice daily and phenobarbital every 12 hours. If seizures continue or serious side effects occur, alternative treatments will be used according to hospital protocols. Participants will be closely monitored for seizure cessation five minutes after infusion and for any seizure recurrence or need for additional treatments within 12 hours. Vital signs such as oxygen levels, pulse, respiratory rate, and blood pressure will be checked before, during, and after infusion at regular intervals to detect any adverse effects. Routine blood tests and other investigations will be performed as needed. The main outcome is whether seizures stop within five minutes of treatment, with secondary outcomes including seizure recurrence, additional medication needs, and adverse effects over the following 12 hours. The study is expected to last until June 2026.

Levetiracetam Versus Phenobarbital in Benzodiazepines Unresponsive Paediatric Prolonged Seizures