Intramuscular midazolam versus intravenous lorazepam for the prehospital treatment of status epilepticus in the pediatric population
| Autor: | Robert D, Welch, Katherine, Nicholas, Valerie L, Durkalski-Mauldin, Daniel H, Lowenstein, Robin, Conwit, Prashant V, Mahajan, Christopher, Lewandowski, Robert, Silbergleit, Jenny, Atas |
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| Rok vydání: | 2014 |
| Předmět: |
Male
Pediatrics medicine.medical_specialty Adolescent Midazolam Population Allied Health Personnel Status epilepticus Lorazepam Injections Intramuscular Article law.invention Young Adult Status Epilepticus Clinical Protocols law Medicine Humans Intensive care medicine education Child education.field_of_study business.industry Infant Emergency department Intensive care unit Clinical trial Treatment Outcome Neurology Child Preschool Cohort Administration Intravenous Anticonvulsants Female Neurology (clinical) medicine.symptom business medicine.drug |
| Zdroj: | Epilepsia. 56(2) |
| ISSN: | 1528-1167 |
| Popis: | Although seizures arise from many etiologies, prolonged seizure activity from any cause is a dangerous neurologic emergency in both adults and children. Regardless of the initially precipitating cause, seizures that do not terminate spontaneously or with early treatment often create positive feedback loops in which the seizure becomes self-perpetuating, resulting in status epilepticus (SE). Despite its many disparate triggers, SE is a relatively homogenous pathophysiologic process for which the initial acute treatment, benzodiazepines, is the same regardless of the etiology or age of the patient.1,2 In the prehospital setting and in the emergency department (ED), conventional first-line therapy for patients with SE is intravenous (IV) diazepam or lorazepam.2,3 However, establishing an IV line in convulsing patients, especially in the prehospital setting, can be challenging and can delay treatment. Intramuscular (IM) delivery of midazolam has been advocated as an alternative treatment, but prior to 2012, it had not been demonstrated to be as safe or effective as IV treatment.4,5 The Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART) was a randomized controlled clinical trial designed to determine whether IM midazolam was non-inferior to IV lorazepam in adults and children with prehospital SE.6 Published in 2012, RAMPART showed that those randomized to IM midazolam were more likely to have terminated seizures prior to ED arrival and were less likely to require hospital ward or intensive care unit (ICU) admission. RAMPART included pediatric patients because children and adolescents constitute a substantial proportion of those with prehospital SE. Preliminary surveys were performed to ensure that the study population would have a sufficient representation of children. Given the consistency of the underlying biology of SE in adults and children, RAMPART was powered to test the primary noninferiority hypothesis in the overall cohort with results applicable to the general population of patients. Although it was not designed to evaluate efficacy separately in either the adult or pediatric subpopulation, the data obtained included a large number of nonadult patients. The RAMPART study represents the largest prospective clinical trial experience with prehospital SE in children and adolescents. The goal of this study is to describe and clinically characterize this unique cohort. Post hoc subgroup analyses by age and safety outcomes by age are also explored. |
| Databáze: | OpenAIRE |
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