The Prehospital Treatment of Status Epilepticus (PHTSE) study: Design and methodology

Daniel H. Lowenstein, Brian K. Alldredge, Faith Allen, John Neuhaus, Megan Corry, Mildred Gottwald, Nelda O'Neil, SueKay Ulrich, S. Marshal Isaacs, Allan Gelb

Research output: Contribution to journalArticle

39 Scopus citations

Abstract

Status epilepticus is a neurological emergency that is typically first encountered and managed in the prehospital environment. Although aggressive pharmacological treatment of status epilepticus is well established in the emergency department and hospital settings, the relative risks and benefits of active therapy for status epilepticus in the prehospital setting are not known. The Prehospital Treatment of Status Epilepticus (PHTSE) study is a prospective, randomized, double-blind, placebo-controlled study designed to address the following aims: (1) to determine whether administration of benzodiazepines by paramedics is an effective and safe means of treating status epilepticus in the prehospital setting and whether this therapy influences longer-term patient outcome, (2) to determine whether lorazepam is superior to diazepam for the treatment of status epilepticus in the prehospital setting, and (3) to determine whether control of status epilepticus prior to arrival to the emergency department influences patient disposition. The initial phase of the PHTSE study began in January 1994 and was completed in February 1999 after the successful enrollment of 205 patients into the three treatment arms. In this paper, we describe the rationale for the conceptualization of the study and details of the study design and methodology, and emphasize some aspects of study implementation that are unique to research involving the emergency medical system.

Original languageEnglish (US)
Pages (from-to)290-309
Number of pages20
JournalControlled Clinical Trials
Volume22
Issue number3
DOIs
StatePublished - Jun 21 2001

Keywords

  • Benzodiazepines
  • Diazepam
  • Emergency medical services
  • Lorazepam
  • Status epilepticus

ASJC Scopus subject areas

  • Pharmacology

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    Lowenstein, D. H., Alldredge, B. K., Allen, F., Neuhaus, J., Corry, M., Gottwald, M., O'Neil, N., Ulrich, S., Isaacs, S. M., & Gelb, A. (2001). The Prehospital Treatment of Status Epilepticus (PHTSE) study: Design and methodology. Controlled Clinical Trials, 22(3), 290-309. https://doi.org/10.1016/S0197-2456(01)00120-9