The prehospital treatment of status epilepticus (PHTSE) study: Design and methodology

Status epilepticus is a neurological emergency that is typically first enco untered and managed in the prehospital environment. Although aggressive pha rmacological treatment of status epilepticus is well established in the eme rgency department and hospital settings, the relative risks and benefits of active therapy for status epilepticus in the prehospital setting are not k nown. The Prehospital Treatment of Status Epilepticus (PHTSE) study is a pr ospective, randomized, double-blind, placebo-controlled study designed to a ddress the following aims: (1) to determine whether administration of benzo diazepines 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 set ting, and (3) to determine whether control of status epilepticus prior to a rrival to the emergency department influences patient disposition. The init ial phase of the PHTSE study began in January 1994 and was completed in Feb ruary 1999 after the successful enrollment of 205 patients into the three t reatment arms. In this paper, we describe the rationale for the conceptuali zation of the study and details of the study design and methodology, and em phasize some aspects of study implementation that are unique to research in volving the emergency medical system. (C) Elsevier Science Inc. 2001.