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Intramuscular Versus Intravenous Therapy for Prehospital Status Epilepticus

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Intramuscular Versus Intravenous Therapy for Prehospital Status Epilepticus The new england journal of medicine established in 1812 february 16, 2012 vol. 366 no. 7 Intramuscular versus Intravenous Therapy for Prehospital Status Epilepticus Robert Silbergleit, M.D., Valerie Durkalski, Ph.D., Daniel Lowenstein, M.D., Robin Conwit, M.D., Arthur Pancioli, M.D., Yuko Palesch, Ph.D., and William Barsan, M.D., for the NETT Investigators* Abstr act Background Early termination of prolonged seizures with intravenous administration of benzodi- From the Department of Emergency azepines improves outcomes. For faster and more reliable administration, paramed- Medicine, University of Michigan, Ann Arbor (R.S., W.B.); the Department of ics increasingly use an intramuscular route. Medicine, Division of Biostatistics and Epidemiology, Medical University of Methods South Carolina, Charleston (V.D., Y.P.); This double-blind, randomized, noninferiority trial compared the efficacy of intra- the Department of Neurology, University muscular midazolam with that of intravenous lorazepam for children and adults in of California, San Francisco, San Francis- co (D.L.); the National Institute of Neuro- status epilepticus treated by paramedics. Subjects whose convulsions had persisted for logical Disorders and Stroke, National more than 5 minutes and who were still convulsing after paramedics arrived were Institutes of Health, Bethesda, MD given the study medication by either intramuscular autoinjector or intravenous infu- (R.C.); and the Department of Emergen- cy Medicine, University of Cincinnati, sion. The primary outcome was absence of seizures at the time of arrival in the emer- Cincinnati (A.P.). Address reprint re- gency department without the need for rescue therapy. Secondary outcomes included quests to Dr. Silbergleit at the Depart- endotracheal intubation, recurrent seizures, and timing of treatment relative to the ces- ment of Emergency Medicine, Suite 3100, 24 Frank Lloyd Wright Dr., Ann Arbor, MI sation of convulsive seizures. This trial tested the hypothesis that intramuscular mid- 48105, or at robert.silbergleit@umich azolam was noninferior to intravenous lorazepam by a margin of 10 percentage points. .edu. Results *The Neurological Emergencies Treatment At the time of arrival in the emergency department, seizures were absent without Trials (NETT) investigators are listed in the Supplementary Appendix, available at rescue therapy in 329 of 448 subjects (73.4%) in the intramuscular-midazolam group NEJM.org. and in 282 of 445 (63.4%) in the intravenous-lorazepam group (absolute difference, 10 percentage points; 95% confidence interval, 4.0 to 16.1; P<0.001 for both noninfe- This article (10.1056/NEJMoa1107494) was updated on February 16, 2012. riority and superiority). The two treatment groups were similar with respect to need for endotracheal intubation (14.1% of subjects with intramuscular midazolam and N Engl J Med 2012;366:591-600. 14.4% with intravenous lorazepam) and recurrence of seizures (11.4% and 10.6%, re- Copyright © 2012 Massachusetts Medical Society. spectively). Among subjects whose seizures ceased before arrival in the emergency de- partment, the median times to active treatment were 1.2 minutes in the intramuscular- midazolam group and 4.8 minutes in the intravenous-lorazepam group, with corresponding median times from active treatment to cessation of convulsions of 3.3 minutes and 1.6 minutes. Adverse-event rates were similar in the two groups. Conclusions For subjects in status epilepticus, intramuscular midazolam is at least as safe and effective as intravenous lorazepam for prehospital seizure cessation. (Funded by the National Institute of Neurological Disorders and Stroke and others; ClinicalTrials.gov number, NCT00809146.) n engl j med 366;7 nejm.org february 16, 2012 591 The New England Journal of Medicine Downloaded from nejm.org at UAMS Library on September 2, 2017. For personal use only. No other uses without permission. Copyright © 2012 Massachusetts Medical Society. All rights reserved. T h e new england journal o f medicine arly termination of prolonged epi- the National Institute of Neurological Disorders leptic seizures in response to intravenous and Stroke (NINDS). The investigators were re- Eadministration of benzodiazepines by para- sponsible for all elements of the trial, including medics in the prehospital setting is associated design, data collection, and analysis. The authors with better patient outcomes. The randomized, wrote the manuscript and vouch for the data and controlled Prehospital Treatment of Status Epilep- analysis. The trial was performed under an Inves- ticus (PHTSE) trial (ClinicalTrials.gov number, tigational New Drug application with the Food NCT00004297) compared diazepam, lorazepam, and Drug Administration (FDA). Autoinjectors and placebo given intravenously by paramedics to with active medication and placebo were pur- treat subjects with prolonged convulsive seizures.1 chased by the Department of Defense and pro- The trial showed that both these benzodiazepines vided to the NINDS through a cooperative agree- were an effective prehospital treatment for seizures, ment. The Department of Defense had no role in as compared with placebo. The proportion of sub- the design of the study, accrual or analysis of jects whose seizures were terminated at the time data, or preparation of the manuscript. The study of arrival in the emergency department was 59.1% was conducted in accordance with the protocol, in the group receiving intravenous lorazepam, which is available with the full text of this article 42.6% in the group receiving intravenous diaze- at NEJM.org. pam, and 21.1% in the group receiving intrave- RAMPART involved 4314 paramedics, 33 EMS nous placebo. agencies, and 79 receiving hospitals across the Many emergency medical services (EMS) sys- United States. Paramedics received continuing tems, however, have begun to use intramuscular medical education in the management of seizures midazolam rather than an intravenous agent, and other neurologic emergencies, as well as sup- largely because intramuscular administration is plemental training in human subjects research and faster and is consistently achievable.2 This prac- protections and in the study protocol, with re- tice has become increasingly common despite the fresher protocol training provided throughout the lack of clinical-trial data regarding the efficacy and trial. safety of intramuscular midazolam. Although in- The trial met the exception from informed- travenous lorazepam is the preferred treatment for consent requirements for emergency research un- patients with seizures in the emergency depart- der the FDA code of regulations 21 CFR 50.24.4 ment (and was the most effective treatment in the Institutional review boards for all entities engaged PHTSE trial), it is rarely used by paramedics in the in this research reviewed local community consul- prehospital setting because of the potential diffi- tation activity, according to the regulations regard- culty with intravenous administration, as well as ing the exception from informed consent, and the short shelf-life of lorazepam when it is not re- provided approval. Subjects or their legally autho- frigerated.3 EMS medical directors need a practical rized representatives were notified about enroll- alternative that is at least as safe and effective as ment in the trial by the study team as soon as intravenous lorazepam. We therefore performed a possible, usually while the subject was still in the noninferiority study to determine whether intra- emergency department, and provided written in- muscular midazolam is as effective as intravenous formed consent to allow continued data collection lorazepam, with a similar degree of safety, for until follow-up was completed. terminating status epilepticus seizures before ar- rival at the hospital. Study Subjects The intended study population included children Methods with an estimated body weight of 13 kg or more and adults requiring treatment with benzodiaze- Study Design pines for status epilepticus in the prehospital set- The Rapid Anticonvulsant Medication Prior to Ar- ting. Subjects were enrolled if they were having rival Trial (RAMPART) was a randomized, double- convulsive seizures at the time of treatment by blind, phase 3, noninferiority clinical trial. It was paramedics and were reported by reliable witness- designed and conducted by the Neurological Emer- es to have been continuously convulsing for longer gencies Treatment Trials (NETT) network, a multi- than 5 minutes or if they were having convulsive disciplinary clinical trials infrastructure funded by seizures at the time of treatment after having in- 592 n engl j med 366;7 nejm.org february 16, 2012 The New England Journal of Medicine Downloaded from nejm.org at UAMS Library on September 2, 2017. For personal use only. No other uses without permission. Copyright © 2012 Massachusetts Medical Society. All rights reserved. Prehospital Control of Status Epilepticus termittent seizures without regaining conscious- oral statements when intramuscular treatment was ness for longer than 5 minutes. administered, when intravenous access was ob- Subjects were excluded for the following rea- tained, when the intravenous study drug was ad- sons: the acute precipitant of the seizures was ministered, when any rescue treatments were giv- major trauma, hypoglycemia, cardiac arrest, or a en, and when convulsions were observed to stop. heart rate of less than 40 beats per minute (since Each statement was time-stamped by the study these conditions require alternative
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