Document Detail


RAMPART (Rapid Anticonvulsant Medication Prior to Arrival Trial): a double-blind randomized clinical trial of the efficacy of intramuscular midazolam versus intravenous lorazepam in the prehospital treatment of status epilepticus by paramedics.
MedLine Citation:
PMID:  21967361     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Early treatment of prolonged seizures with benzodiazepines given intravenously by paramedics in the prehospital setting has been shown to be associated with improved outcomes. However, an increasing number of Emergency Medical System (EMS) protocols use an intramuscular (IM) route because it is faster and consistently achievable. RAMPART (Rapid Anticonvulsant Medication Prior to Arrival Trial) is a double-blind randomized clinical trial to determine if the efficacy of IM midazolam is noninferior by a margin of 10% to that of intravenous (IV) lorazepam in patients treated by paramedics for status epilepticus (SE). Children and adults with >5 min of convulsions who are still seizing after paramedic arrival are administered study medication by IM autoinjector or IV infusion. The primary efficacy outcome is absence of seizures at emergency department (ED) arrival, without EMS rescue therapy. Safety outcomes include acute endotracheal intubation and recurrent seizures. Secondary outcomes include timing of treatment and initial seizure cessation. At the time of writing this communication, enrollment of all subjects is near completion and the study data will soon be analyzed.
Authors:
Robert Silbergleit; Daniel Lowenstein; Valerie Durkalski; Robin Conwit;
Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural    
Journal Detail:
Title:  Epilepsia     Volume:  52 Suppl 8     ISSN:  1528-1167     ISO Abbreviation:  Epilepsia     Publication Date:  2011 Oct 
Date Detail:
Created Date:  2011-10-04     Completed Date:  2011-11-15     Revised Date:  2014-09-24    
Medline Journal Info:
Nlm Unique ID:  2983306R     Medline TA:  Epilepsia     Country:  United States    
Other Details:
Languages:  eng     Pagination:  45-7     Citation Subset:  IM    
Copyright Information:
Wiley Periodicals, Inc. © 2011 International League Against Epilepsy.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00809146
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MeSH Terms
Descriptor/Qualifier:
Allied Health Personnel*
Anticonvulsants / administration & dosage*
Emergency Medical Services
Humans
Injections, Intramuscular / methods
Injections, Intraventricular / methods
Lorazepam / administration & dosage*
Midazolam / administration & dosage*
Status Epilepticus / drug therapy*
Treatment Outcome
Grant Support
ID/Acronym/Agency:
5U01NS056975-04/NS/NINDS NIH HHS; U01 NS056975/NS/NINDS NIH HHS; U01 NS056975-05/NS/NINDS NIH HHS; U01 NS059041/NS/NINDS NIH HHS; U01 NS059041-01/NS/NINDS NIH HHS; U10 NS058960/NS/NINDS NIH HHS
Chemical
Reg. No./Substance:
0/Anticonvulsants; O26FZP769L/Lorazepam; R60L0SM5BC/Midazolam
Comments/Corrections

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