|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
National Institute of Neurological Disorders and Stroke (NINDS) University of Michigan Medical University of South Carolina University of California, San Francisco |
|---|---|
| Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
| ClinicalTrials.gov Identifier: | NCT00809146 |
Purpose
The goal of this trial is to determine which type of routine care is the best for paramedics to stop someone from seizing.
| Condition | Intervention | Phase |
|---|---|---|
|
Status Epilepticus |
Other: Route of administration |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 750 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
IM: Active Comparator
IM administration by autoinjector of midazolam 5 mg for subjects under estimated weight of 40 kg or midazolam 10 mg for subjects with estimated weight of 40 kg or above, IV administration of matching volume of IV flush.
|
Other: Route of administration
Route of anticonvulsant administration in prehospital treatment, IM versus IV
|
|
IV: Active Comparator
IV administration of lorazepam 2 mg for subjects under estimated weight of 40 kg or midazolam 4 mg for subjects with estimated weight of 40 kg or above, IM administration by autoinjector of matching volume of saline.
|
Other: Route of administration
Route of anticonvulsant administration in prehospital treatment, IM versus IV
|
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. Many paramedics start medicine directly into a vein or intravenously (IV). This works well, but is 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 or intramuscularly (IM). 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 750 persons with continuing seizure activity after emergency medical service (EMS) arrival and who meet all eligibility criteria will be enrolled in the trial. Each participant will be treated with anti-seizure medicine by the paramedics. Participants will be randomly chosen to 1 of 2 groups. Group 1 will receive the study medicine through an IV and will be given a shot in the muscle without medicine (placebo). Group 2 will receive the medicine as a shot in the muscle plus an IV without medicine (placebo).
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Robert Silbergleit, MD | 724-232-2142 | robie@umich.edu |
| United States, California | |
| Stanford University | Recruiting |
| Palo Alto, California, United States, 94304-5777 | |
| Contact: James Quinn, MD 650-736-4391 jquinn@stanfordmed.org | |
| United States, Ohio | |
| University of Cincinnati Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45267 | |
| Contact: Arthur Pancioli, MD 513-558-8103 pancioam@ucmail.uc.edu | |
| Principal Investigator: | Robert Silbergleit, MD | University of Michigan |
More Information
| Responsible Party: | University of Michigan ( Robert Silbergleit, MD, Principal Investigator ) |
| Study ID Numbers: | R01NS053031, 5U01NS056975-02 |
| Study First Received: | December 15, 2008 |
| Last Updated: | April 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00809146 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Status Epilepticus Emergency Medical Services Anticonvulsants Drug Administration Routes Seizures |
|
Lorazepam Epilepsy Status Epilepticus Seizures Central Nervous System Diseases |
Emergencies Midazolam Brain Diseases Anticonvulsants |
|
Epilepsy Therapeutic Uses Status Epilepticus Nervous System Diseases Central Nervous System Diseases |
Brain Diseases Central Nervous System Agents Pharmacologic Actions Anticonvulsants |
