Paramedic Treatment of Prolonged Seizures by Intramuscular Versus Intravenous Anticonvulsant Medications

Condition(s) targeted: Status Epilepticus

Intervention: Intramuscular route of active treatment (Other); Intravenous route of active treatment (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: University of Michigan

Official(s) and/or principal investigator(s):
Robert Silbergleit, MD, Principal Investigator, Affiliation: University of Michigan

Overall contact:
Robert Silbergleit, MD, Phone: 724-232-2142, Email: robie@umich.edu

The goal of this trial is to determine which type of routine care is the best for paramedics to stop someone from seizing.

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: The binary outcome variable measuring whether or not there is termination of convulsive seizure activity prior to ED arrival after an initial dose of study medication without the need for a second rescue dose of benzodiazepine by EMS

Secondary outcome: Times from EMS arrival to convulsive seizure termination & from treatment initiation to seizure termination, frequency of endotracheal intubation, frequency & duration of hospitalization & ICU admission, & frequency of acute seizure recurrence.

Detailed description: 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 is designed to figure out whether giving anti-seizure medicine works better 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 800 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).

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Paramedics or reliable witnesses verify 5 minutes of either continuous seizure

activity or of repeated convulsive seizure activity where the patient does not regain consciousness (operationally defined as meaningful speech or obeying commands) between seizures.

- Patient is still seizing at the time of paramedic treatment with study medications.

- Estimated weight equal to or greater than 13 kg.

- Subject to be transported to a RAMPART participating hospital.

Exclusion Criteria:

- Major trauma as the precipitant of the seizure

- Hypoglycemia (as defined by local EMS protocol or a glucose < 60 mg/dL)

- Known allergy to midazolam or lorazepam

- Cardiac arrest or heart rate (HR) <40 beats per minute

- Sensitivity to benzodiazepines

- Medical alert tag marked with "RAMPART declined"

- Prior treatment of this seizure with diazepam autoinjector as part of another study

- Known pregnancy

- Prisoners

Robert Silbergleit, MD, Phone: 724-232-2142, Email: robie@umich.edu

University of Arizona, Tucson, Arizona 85742, United States; Recruiting
Kurt Denninghoff, MD, Phone: 520-626-1551, Email: kdenninghoff@aemrc.arizona.edu
Bruce Barnhart, Email: BBarnhart@aemrc.arizona.edu
Kurt Denninghoff, MD, Principal Investigator
Daniel Spaite, MD, Sub-Investigator

Stanford University, Palo Alto, California 94304-5777, United States; Recruiting
James Quinn, MD, Phone: 650-736-4391, Email: jquinn@stanfordmed.org
Stephanie Casal, Email: scasal@stanford.edu
James V Quinn, MD, Principal Investigator

University of California-San Francisco, San Francisco, California 94110, United States; Recruiting
Claude Hemphill, MD, Phone: 415-206-3213, Email: chemphill@sfgh.ucsf.edu
Michele Meeker, RN, Email: meekerm@neurosurg.ucsf.edu
Claude Hemphill, MD, Principal Investigator
Karl Sporer, MD, Sub-Investigator

Emory University, Atlanta, Georgia 30303, United States; Recruiting
David Wright, MD, Phone: 404-778-1709, Email: David.Wright@Emory.edu
Harriet Howlett-Smith, RN, Email: hhowlet@emory.edu
David Wright, MD, Principal Investigator
Bittner Matthew, MD, Sub-Investigator

University of Kentucky, Lexington, Kentucky 40536-0298, United States; Recruiting
Roger Humphries, MD, Phone: 859-323-5908, Email: rlhump0@uky.edu
Christofer Sweat, Email: sweatclfd@gmail.com
Roger Humphries, MD, Principal Investigator

Wayne State University, Detroit, Michigan 48202, United States; Recruiting
Robert Welch, MD, Phone: 313-993-2534, Email: rwelch@med.wayne.edu
LynnMarie Mango, Email: lmmango@med.wayne.edu
Robert Welch, MD, Principal Investigator

Henry Ford Health System, Detroit, Michigan 48202, United States; Recruiting
Christopher Lewandowski, MD, Phone: 313-916-1553, Email: clewand1@hfhs.org
Paula Crouse, Email: PCROUSE1@hfhs.org
Christopher Lewandowski, MD, Principal Investigator

University of Minnesota, Minneapolis, Minnesota 55414, United States; Recruiting
Michelle Biros, MD, Phone: 612-873-7586, Email: michelle.biros@gmail.com
Corey Sargent, Email: sarge022@umn.edu
Michelle H Biros, MD, Principal Investigator

University of Cincinnati Medical Center, Cincinnati, Ohio 45267, United States; Recruiting
Arthur Pancioli, MD, Phone: 513-558-8103, Email: pancioam@ucmail.uc.edu
Irene Ewing, RN, Email: irene.ewing@uc.edu
Arthur Pancioli, MD, Principal Investigator
Jason McMullan, MD, Sub-Investigator

Oregon Health and Science University, Portland, Oregon 97239-3098, United States; Recruiting
Robert Lowe, MD, Phone: 503-494-7551, Email: lowero@ohsu.edu
Rachel Stone, Email: stonera@ohsu.edu
Robert Lowe, MD, Principal Investigator
Craig Warden, MD, Sub-Investigator

University of Pennsylvania/York, Philadelphia, Pennsylvania 19104, United States; Recruiting
Jill Baren, MD, Phone: 215-662-6917, Email: barenj@uphs.upenn.edu
Katie Lamond, Email: Katherine.Lamond@uphs.upenn.edu
Jill Baren, MD, Principal Investigator
R. Daniel Bledsoe, MD, Sub-Investigator

Temple University, Philadelphia, Pennsylvania 19140, United States; Not yet recruiting
Nina Gentile, MD, Email: ngentile@temple.edu
Christopher Vates, Email: cvates@temple.edu
Nina Gentile, MD, Principal Investigator

University of Texas-Houston, Houston, Texas 77030, United States; Not yet recruiting
Elizabeth Jones, MD, Phone: 713-500-7864, Email: Elizabeth.B.Jones@uth.tmc.edu
Misty Ottman, Email: misty.ottman@uth.tmc.edu
Elizabeth Jones, MD, Principal Investigator
Bonnie Richter, MD, Sub-Investigator

Virginia Commonwealth University, Richmond, Virginia 23298, United States; Recruiting
Joseph Ornato, MD, Phone: 804-828-7184, Email: jpornato@vcu.edu
Michael Kurz, Email: mkurz@mcvh-vcu.edu
Joseph P Ornato, MD, Principal Investigator
Michael Kurz, MD, Sub-Investigator

Starting date: June 2009
Ending date: June 2012
Last updated: September 28, 2009