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Brivaracetam is increasingly being studied in adult status epilepticus populations, evidence in pediatric patients remains sparse, with only limited case series and observational studies reporting favorable outcomes. This study aims at direct comparison between intravenous brivaracetam and levetiracetam in the acute management of pediatric status epilepticus.
Given the urgent need for safe and effective alternatives in pediatric status epilepticus and the limited head-to-head data comparing intravenous brivaracetam with levetiracetam, especially in children, this study has been designed to evaluate their relative safety and efficacy. The research seeks to generate evidence that may help guide clinical decision-making and optimize outcomes in this vulnerable population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brivaracetam group | Experimental | Patients received brivaracetam as a loading dose of 2 mg/kg (maximum 100 mg) diluted in 100 ml of normal saline infused over 10 minutes. |
|
| Levetiracetam group | Experimental | Patients received levetiracetam as a loading dose of 40 mg/kg (maximum 3000 mg) diluted in 100 ml of normal saline infused over 10 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous brivaracetam | Drug | Patients received intravenous brivaracetam as a loading dose of 2 mg/kg (maximum 100 mg) diluted in 100 ml of normal saline infused over 10 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Cessation of seizures | Cessation of seizures was labeled "yes" if cessation of clinical seizures occurred within 20-30 minutes of infusion without the need for additional antiseizure medication. | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Labeled "yes" if any treatment-related adverse event reported 30 minutes post-infusion. | 40 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ikram Rahman | Children's Hospital and institute of Child Health, Multan, Pakistan | Principal Investigator |
| Nuzhat Noureen, FCPS | Children's Hospital and institute of Child Health, Multan, Pakistan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital and Institute of Child Health | Multan | Punjab Province | 66000 | Pakistan |
Data can be shared on a reasonable request.
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| ID | Term |
|---|---|
| D013226 | Status Epilepticus |
| ID | Term |
|---|---|
| D012640 | Seizures |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| Intravenous levetiracetam | Drug | Patients received intravenous levetiracetam as a loading dose of 40 mg/kg (maximum 3000 mg) diluted in 100 ml of normal saline infused over 10 minutes. |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |