Status Epilepticus Clinical Trial
Official title:
A Double-blind Randomized Clinical Trial of the Efficacy of IM Midazolam Versus IV Lorazepam in the Pre-hospital Treatment of Status Epilepticus by Paramedics
The goal of this non-inferiority trial is to determine which type of routine care is the best for paramedics to stop someone from seizing.
Seizures are a common medical problem. Although they can be frightening to watch, most
seizures are brief and stop by themselves. Seizures that don't stop in seconds or minutes
are a dangerous life-threatening medical emergency. Paramedics often have medications that
can stop seizures, but the best way to give the medicines is not known. Paramedics often
give medicine directly into a vein, which is called intravenous (IV) administration. This
works well, but can be hard to do in a person who is seizing. It can also take some time and
delay treatment. Another way to give the medicine is as a shot given into a muscle, which is
called intramuscular (IM) administration. Giving the medicine this way is faster, but it may
not stop the seizure as quickly.
This clinical trial, the Rapid Anti-convulsant Medication Prior to ARrival Trial (RAMPART),
is designed to figure out whether giving anti-seizure medicine works similarly well and more
quickly when given through an IV or when given as a shot in the muscle. Two similar
medicines will be used. Both are already used by paramedics in the field and by doctors in
the hospital to stop seizures. One is commonly given by IV, and the other is commonly given
as a shot in the muscle. In this study, the shot will be given using a device similar to an
EpiPen—which is an autoinjector used by people with severe allergies.
Approximately 1,024 persons whose seizures are continuing after emergency medical service
(EMS) arrival and who meet all eligibility criteria will be enrolled in the trial. Every
participant will be treated with anti-seizure medicine by the paramedics. At random, half
the participants will be in one group and half in another. Half the participants will
receive the study medicine through an IV and will be given a shot in the muscle without
medicine (placebo). The other half will receive the medicine as a shot in the muscle plus an
IV without medicine (placebo).
In September 2010, more rapid than expected enrollment made it feasible to increase the
sample size of the study from 800 to 1,024 with the already available funding. The goals of
the expansion were to enroll more pediatric subjects (since the trial was enrolling slightly
fewer than anticipated) and to improve the power of the study to 90%, which was initially
desired. It is important to understand that the extended enrollment was not a sample size
re-estimation in any way. The opportunity to extend the trial is pragmatic, based solely on
the early enrollment success of the trial. It is not informed by the planned interim
analyses that have been performed, the results of which remain sequestered, and there have
been no unscheduled interim analyses. The firewall that prevents the blinded leadership from
any knowledge of the outcome data has been diligently maintained throughout the process of
proposing and implementing this extension.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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