Intramuscular versus Intravenous Therapy for Prehospital Status Epilepticus
By R. Silbergleit, Valerie L. Durkalski, D. Lowenstein, R. Conwit, A. Pancioli, Y. Palesch, William Barsan. New England Journal of Medicine, 2012
645 citations recorded by the source corpus.
BACKGROUND Early termination of prolonged seizures with intravenous administration of benzodiazepines improves outcomes. For faster and more reliable administration, paramedics increasingly use an intramuscular route. METHODS This double-blind, randomized, noninferiority trial compared the efficacy of intramuscular midazolam with that of intravenous lorazepam for children and adults in status epilepticus treated by paramedics. Subjects whose convulsions had persisted for more than 5 minutes and who were still convulsing after paramedics arrived were given the study medication by either intramuscular autoinjector or intravenous infusion. The primary outcome was absence of seizures at the time of arrival in the emergency department without the need for rescue therapy. Secondary outcomes included endotracheal intubation, recurrent seizures, and timing of treatment relative to the cessation of convulsive seizures. This trial tested the hypothesis that intramuscular midazolam was noninferior to intravenous lorazepam by a margin of 10 percentage points. RESULTS At the time of arrival in the emergency department, seizures were absent without rescue therapy in 329 of 448 subjects (73.4%) in the intramuscular-midazolam group 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 noninferiority and superiority). The two treatment groups were similar with respect to need for endotracheal intubation (14.1% of subjects with intramuscular midazolam and 14.4% with intravenous lorazepam) and recurrence of seizures (11.4% and 10.6%, respectively). Among subjects whose seizures ceased before arrival in the emergency department, 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.)
Subfields: Emergency Medicine, Pediatrics, Perinatology and Child Health, Psychiatry and Mental health
View Paper: https://www.semanticscholar.org/paper/b920cac14de7c5a42ef100935145db4594e07cd0
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Citations in the corpus
- Guidelines for the Evaluation and Management of Status Epilepticus (2012, positive): “IM midazolam was found to be at least as effective as IV lorazepam in prehospitalized patients with SE [84].”
- Status Epilepticus. (2016, background): “Thus, prehospital treatment protocols, which have been shown to be safe and effective in several excellent randomized controlled trials (RCTs), are of utmost importance (Alldredge et al. 2001; Silbergleit et al. 2012).”
- Evidence-Based Guideline: Treatment of Convulsive Status Epilepticus in Children and Adults: Report of the Guideline Committee of the American Epilepsy Society (2016, background): “Pediatric Studies Overall, 26 RCTs (two class I [24, 34] and 24 class III [27, 30, 35–56]) examined efficacy of initial therapy.”