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Randomized Controlled Trial
. 2011 Oct;52 Suppl 8(Suppl 8):45-7.
doi: 10.1111/j.1528-1167.2011.03235.x.

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

Robert Silbergleit  1 , Daniel Lowenstein, Valerie Durkalski, Robin Conwit; Neurological Emergency Treatment Trials (NETT) Investigators
Affiliations
Randomized Controlled Trial

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

Robert Silbergleit et al. Epilepsia. 2011 Oct.

Abstract

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.

Trial registration: ClinicalTrials.gov NCT00809146.

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Conflict of interest statement

Disclsoures: The authors confirm that they have no conflicts of interest to declare. The authors confirm that they have read the Journal's position on issues involved in ethical publication and affirm that this report is consistent with those guidelines.

Figures

Figure 1
Figure 1
Projected versus actual subject accrual for RAMPART
See this image and copyright information in PMC

References

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