A comparison of intravenous levetiracetam and phenytoin combination versus phenytoin and placebo combination in children with benzodiazepine resistant convulsive epileptics -a double blinded randomised control trail
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- To compare the proportion of children with successful clinical termination of seizure activity within 30 min after initiation of drug infusion in either group (Phenytoin and Levitracetam versus Phenytoin and placebo )
Study Overview
Brief Summary
Status Epilepticus (SE) being one of the most common life threatening neurological emergency in children requires a prompt intervention for early control of seizures to prevent short term and long term morbidity. There is increased mortality and morbidity due to not only the cause and duration of SE but also its management.Current antiepileptic drugs for SE are given in succession to achieve seizure control.We want to shorten the delay in seizure control and also increase the proportion of seizure control by combining two antiepileptic drugs acting at two different sites, by administering them simultaneously and rapidly. Research question: Whether Levetiracetam and phenytoin combination is better in seizure control than phenytoin and placebo combination in children with benzodiazepine resistant status epilepticus. study location: Pediatric ER and PICU of Advanced Pediatric Center , PGIMER , Chandigarh In this study it is proposed to give injection phenytoin and levetiracetam concurrently in SE not responding to initial 2 doses of benzodiazepine, in children aged 3months-12yrs. The primary objective: Proportion of seizure control within 30 minutes of starting drug infusion Secondary objective: Recurrence of seizure with in 8 hours , correlating seizure control with drug levels of phenytoin and levetiracetam at end of 1 hour of infusion and adverse effects of the study drugs.
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, variable
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 3.00 Month(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Children aged 3month to 12 years presenting with convulsive status epilepticus(CSE) or occurrence of status epilepticus at pediatric Emergency or PICU of advanced pediatric center of PGIMER Eligibility criteria: Minimum two doses of benzodiazepines as first line treatment is to be given.
Exclusion Criteria
- •4.3.1.Absence, myoclonic, non-convulsive status epilepticus, or infantile spasms Known case of chronic renal disease Previous administration of loading any IV antiepileptic drug within last 12 hours of enrollment.
Outcomes
Primary Outcomes
To compare the proportion of children with successful clinical termination of seizure activity within 30 min after initiation of drug infusion in either group (Phenytoin and Levitracetam versus Phenytoin and placebo )
Time Frame: within 30 minutes of starting the drug infusions
Secondary Outcomes
- To compare the proportion of children with recurrence of seizure within 8 hours of stopping infusionCorrelation of serum drug levels of levetiracetam and phenytoin with seizure control(To compare the proportion of children with adverse events due to either phenytoin and levetiracetam combination or phenytoin and placebo combination)