Intramuscular versus Intravenous Therapy for Prehospital Status Epilepticus
In this trial, subjects in status epilepticus were given either intramuscular midazolam or intravenous lorazepam by paramedics before arrival in the ER. Seizures were controlled in more subjects with midazolam, and midazolam was at least as safe and effective as lorazepam. Early termination of prolo...
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| Published in | The New England journal of medicine Vol. 366; no. 7; pp. 591 - 600 |
|---|---|
| Main Authors | , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Waltham, MA
Massachusetts Medical Society
16.02.2012
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| Subjects | |
| Online Access | Get full text |
| ISSN | 0028-4793 1533-4406 1533-4406 |
| DOI | 10.1056/NEJMoa1107494 |
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| Abstract | In this trial, subjects in status epilepticus were given either intramuscular midazolam or intravenous lorazepam by paramedics before arrival in the ER. Seizures were controlled in more subjects with midazolam, and midazolam was at least as safe and effective as lorazepam.
Early termination of prolonged epileptic seizures in response to intravenous administration of benzodiazepines by paramedics in the prehospital setting is associated with better patient outcomes. The randomized, controlled Prehospital Treatment of Status Epilepticus (PHTSE) trial (ClinicalTrials.gov number, NCT00004297) compared diazepam, lorazepam, and placebo given intravenously by paramedics to treat subjects with prolonged convulsive seizures.
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The trial showed that both these benzodiazepines were an effective prehospital treatment for seizures, as compared with placebo. The proportion of subjects whose seizures were terminated at the time of arrival in the emergency department was 59.1% in the group receiving intravenous lorazepam, 42.6% in the . . . |
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| AbstractList | BackgroundEarly termination of prolonged seizures with intravenous administration of benzodiazepines improves outcomes. For faster and more reliable administration, paramedics increasingly use an intramuscular route.MethodsThis 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.ResultsAt 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.ConclusionsFor 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, ClinicalTrials.gov NCT00809146.) In this trial, subjects in status epilepticus were given either intramuscular midazolam or intravenous lorazepam by paramedics before arrival in the ER. Seizures were controlled in more subjects with midazolam, and midazolam was at least as safe and effective as lorazepam. Early termination of prolonged epileptic seizures in response to intravenous administration of benzodiazepines by paramedics in the prehospital setting is associated with better patient outcomes. The randomized, controlled Prehospital Treatment of Status Epilepticus (PHTSE) trial (ClinicalTrials.gov number, NCT00004297) compared diazepam, lorazepam, and placebo given intravenously by paramedics to treat subjects with prolonged convulsive seizures. 1 The trial showed that both these benzodiazepines were an effective prehospital treatment for seizures, as compared with placebo. The proportion of subjects whose seizures were terminated at the time of arrival in the emergency department was 59.1% in the group receiving intravenous lorazepam, 42.6% in the . . . Early termination of prolonged seizures with intravenous administration of benzodiazepines improves outcomes. For faster and more reliable administration, paramedics increasingly use an intramuscular route.BACKGROUNDEarly termination of prolonged seizures with intravenous administration of benzodiazepines improves outcomes. For faster and more reliable administration, paramedics increasingly use an intramuscular route.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.METHODSThis 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.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.RESULTSAt 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.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, ClinicalTrials.gov NCT00809146.).CONCLUSIONSFor 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, ClinicalTrials.gov NCT00809146.). Early termination of prolonged seizures with intravenous administration of benzodiazepines improves outcomes. For faster and more reliable administration, paramedics increasingly use an intramuscular route. 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. 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. 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, ClinicalTrials.gov NCT00809146.). |
| Author | Palesch, Yuko Durkalski, Valerie Lowenstein, Daniel Pancioli, Arthur Silbergleit, Robert Barsan, William Conwit, Robin |
| Author_xml | – sequence: 1 givenname: Robert surname: Silbergleit fullname: Silbergleit, Robert – sequence: 2 givenname: Valerie surname: Durkalski fullname: Durkalski, Valerie – sequence: 3 givenname: Daniel surname: Lowenstein fullname: Lowenstein, Daniel – sequence: 4 givenname: Robin surname: Conwit fullname: Conwit, Robin – sequence: 5 givenname: Arthur surname: Pancioli fullname: Pancioli, Arthur – sequence: 6 givenname: Yuko surname: Palesch fullname: Palesch, Yuko – sequence: 7 givenname: William surname: Barsan fullname: Barsan, William |
| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=25501377$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/22335736$$D View this record in MEDLINE/PubMed |
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| CODEN | NEJMAG |
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| Contributor | Moheet, Asma Welch, Robert D Quinn, James V Smith, Wade Mango, Lynnmarie Wright, David W Schwartz, Hamilton Lewandowski, Christopher A Didonato, Pete Jones, Elizabeth Nakagawa, Kazuma McMullan, Jason Hebig, Anke Kade, Allison Palesch, Yuko Durkalski, Valerie Harney, Deneil Hemphill, 3rd, J Claude Baker, Anna E Wong, Christine Vohra, Taher T Duncan, Jeany Sherwin, Robert Silbergleit, Robert Vonderschmidt, M Kay Gagai, Nick Wu, Qi Linzer, Sr, Jeffrey F Knight, William Gelb, Alan Pancioli, Arthur Bobrow, Bentley J Pinkerton, Joy Dillon, Catherine Milling, Truman J Casal, Stephanie Mercer, Mary Zaleski, Erin Spaite, Daniel W Stevenson, Valerie Lowenstein, Daniel Brenne, Phebe Harsh, Donna Bitner, Matthew D Levy, Phillip Stettler, Brian Vonderschmidt, Kay Barnhart, Bruce Ewing, Irene Waymeyer, Peggy Ring, Catherin D'Souza, Peter Grise, Erin Heitsch, Laura Ottman, Misty Russman, Andrew N Mika, Valerie H Velilla, Marc-Anthony Pinawin, Ashley Ramanujam, Prasanthi Merck, Lisa H Barsan, William Liao, Mark Rosborough, Kelley King, Ben Naravetla, Bharath Adeoye, |
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| Copyright | Copyright © 2012 Massachusetts Medical Society. All rights reserved. 2015 INIST-CNRS Copyright © 2012 Massachusetts Medical Society. 2012 |
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| DOI | 10.1056/NEJMoa1107494 |
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| Keywords | Medicine Nervous system diseases Prehospital period Treatment Intravenous administration Subintrant crisis Epilepsy Central nervous system disease Status epilepticus Intramuscular administration Comparative study Cerebral disorder |
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| References | Lowenstein, DH, Alldredge, BK, Allen, F (r005) 2001; 22 Chamberlain, JM, Altieri, MA, Futterman, C, Young, GM, Ochsenschlager, DW, Waisman, Y (r011) 1997; 13 Guidance for industry: non-inferiority clinical trials (draft guidance). Washington, DC: Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), 2010 ( ). Millikan, D, Rice, B, Silbergleit, R (r010) 2009; 27 Dunnett, CW, Gent, M (r006) 1977; 33 McMullan, J, Sasson, C, Pancioli, A, Silbergleit, R (r008) 2010; 17 Gottwald, MD, Akers, LC, Liu, PK (r003) 1999; 17 Warden, CR, Frederick, C (r002) 2006; 10 Alldredge, BK, Gelb, AM, Isaacs, SM (r001) 2001; 345 Lowenstein, DH, Alldredge, BK (r009) 1998; 338 Exception from informed consent requirements for emergency research: Code of Federal Regulations. Washington, DC: Government Printing Office ( ). r006 r008 r009 r002 r003 r005 r010 r011 r001 22591303 - N Engl J Med. 2012 May 17;366(20):1943; author reply 1944. doi: 10.1056/NEJMc1203428#SA1. 22591304 - N Engl J Med. 2012 May 17;366(20):1943-4; author reply 1944. doi: 10.1056/NEJMc1203428. 22335744 - N Engl J Med. 2012 Feb 16;366(7):659-60. doi: 10.1056/NEJMe1114206. 23001523 - J Neurol. 2012 Oct;259(10):2261-3. doi: 10.1007/s00415-012-6673-5. |
| References_xml | – volume: 33 start-page: 593 year: 1977 end-page: 602 ident: r006 article-title: Significance testing to establish equivalence between treatments, with special reference to data in the form of 2×2 tables. publication-title: Biometrics – volume: 27 start-page: 101 year: 2009 end-page: 113 ident: r010 article-title: Emergency treatment of status epilepticus: current thinking. publication-title: Emerg Med Clin North Am – volume: 338 start-page: 970 year: 1998 end-page: 976 ident: r009 article-title: Status epilepticus. publication-title: N Engl J Med – volume: 10 start-page: 463 year: 2006 end-page: 467 ident: r002 article-title: Midazolam and diazepam for pediatric seizures in the prehospital setting. publication-title: Prehosp Emerg Care – reference: Guidance for industry: non-inferiority clinical trials (draft guidance). Washington, DC: Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), 2010 ( ). – volume: 17 start-page: 575 year: 2010 end-page: 582 ident: r008 article-title: Midazolam versus diazepam for the treatment of status epilepticus in children and young adults: a meta-analysis. publication-title: Acad Emerg Med – volume: 17 start-page: 333 year: 1999 end-page: 337 ident: r003 article-title: Prehospital stability of diazepam and lorazepam. publication-title: Am J Emerg Med – volume: 13 start-page: 92 year: 1997 end-page: 94 ident: r011 article-title: A prospective, randomized study comparing intramuscular midazolam with intravenous diazepam for the treatment of seizures in children. publication-title: Pediatr Emerg Care – reference: Exception from informed consent requirements for emergency research: Code of Federal Regulations. Washington, DC: Government Printing Office ( ). – volume: 22 start-page: 290 year: 2001 end-page: 309 ident: r005 article-title: The Prehospital Treatment of Status Epilepticus (PHTSE) study: design and methodology. publication-title: Control Clin Trials – volume: 345 start-page: 631 year: 2001 end-page: 637 ident: r001 article-title: A comparison of lorazepam, diazepam, and placebo for the treatment of out-of-hospital status epilepticus. publication-title: N Engl J Med – ident: r005 doi: 10.1016/S0197-2456(01)00120-9 – ident: r011 doi: 10.1097/00006565-199704000-00002 – ident: r006 doi: 10.2307/2529457 – ident: r008 doi: 10.1111/j.1553-2712.2010.00751.x – ident: r010 doi: 10.1016/j.emc.2008.12.001 – ident: r001 doi: 10.1056/NEJMoa002141 – ident: r002 doi: 10.1080/10903120600885126 – ident: r003 doi: 10.1016/S0735-6757(99)90079-7 – ident: r009 doi: 10.1056/NEJM199804023381407 – reference: 22591303 - N Engl J Med. 2012 May 17;366(20):1943; author reply 1944. doi: 10.1056/NEJMc1203428#SA1. – reference: 22335744 - N Engl J Med. 2012 Feb 16;366(7):659-60. doi: 10.1056/NEJMe1114206. – reference: 22591304 - N Engl J Med. 2012 May 17;366(20):1943-4; author reply 1944. doi: 10.1056/NEJMc1203428. – reference: 23001523 - J Neurol. 2012 Oct;259(10):2261-3. doi: 10.1007/s00415-012-6673-5. |
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| Snippet | In this trial, subjects in status epilepticus were given either intramuscular midazolam or intravenous lorazepam by paramedics before arrival in the ER.... Early termination of prolonged seizures with intravenous administration of benzodiazepines improves outcomes. For faster and more reliable administration,... BackgroundEarly termination of prolonged seizures with intravenous administration of benzodiazepines improves outcomes. For faster and more reliable... |
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| SubjectTerms | Adolescent Adult Anticonvulsants - administration & dosage Anticonvulsants - adverse effects Biological and medical sciences Child Child, Preschool Children Clinical trials Consent Convulsions Data collection Double-Blind Method Drug dosages Emergency medical care Emergency Medical Services Epilepsy Federal regulation Female General aspects Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy Humans Hypnotics and Sedatives - administration & dosage Infant Infusions, Intravenous Injections, Intramuscular Intravenous administration Intubation Lorazepam Lorazepam - administration & dosage Lorazepam - adverse effects Male Medical sciences Midazolam Midazolam - administration & dosage Midazolam - adverse effects Middle Aged Nervous system (semeiology, syndromes) Neurological diseases Neurological disorders Neurology Pharmacy R&D Recurrence Research & development Seizures Status Epilepticus - drug therapy Stroke Time Factors Treatment Outcome |
| Title | Intramuscular versus Intravenous Therapy for Prehospital Status Epilepticus |
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