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Efficacy of levetiracetam versus phenytoin in children with convulsive status epilepticus, Single blinded Randomized controlled trial

Is intravenous (IV) levetiracetam or IV phenytoin better to terminate seizures when used as a second line treatment for the emergency management of convulsive status epilepticus (CSE) in children.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001326583
Acronym
none
Enrollment
134
Registered
2024-10-31
Start date
2025-01-01
Completion date
2025-06-30
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Our study is Randomized Controlled trial and it aims to collect evidence regarding superiority of levetiracetam over phenytoin as a second line drug used in management of status epilepticus in children. This will help in development of future guidelines and amendments in existing protocols regarding management of status epilepticus .Outcome will be measured as presence or absence of seizures at 15 minutes and 30 minutes time points after completion of infusion of each drug.

Interventions

Participants assigned to levetiracetam group will receive 40 mg/kg intravenous levetiracetam infusion over 5 min (maximum 2.5g, diluted with 0·9% sodium chloride) and emergency doctor attending that patient will document the prescribed infusion in patient file and monitor the clinical signs for cessation of seizures.

Sponsors

Dr Hina Parvaiz- Medical Teaching Institute Lady Reading Hospital Peshawar
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
2 Months to 15 Years
Healthy volunteers
No

Inclusion criteria

: children between age of 2 months to 15 years presenting with convulsive status epilepticus and having received two doses of benzodiazepines as first line anticonvulsant.

Exclusion criteria

Children who received second line anticonvulsants already or become seizure free after first two doses of benzodiazepines will be excluded. Children with chronic liver disease or kidney disease or any metabolic diseases, causing derangements in blood glucose levels or electrolytes derangements. Children with head trauma will also be excluded. Children with any history of allergy to phenytoin or levetiracetam will also be excluded

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026