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Paramedic Treatment of Prolonged Seizures by Intramuscular Versus Intravenous Anticonvulsant Medications

NCT00809146 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1023

Last updated 2016-06-17

Study results available
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Summary

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.

Conditions

  • Status Epilepticus

Interventions

DRUG

Intramuscular route of active treatment

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.

DRUG

Intravenous route of active treatment

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.

Sponsors & Collaborators

  • Medical University of South Carolina

    collaborator OTHER

  • University of California, San Francisco

    collaborator OTHER

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Robert Silbergleit

    lead OTHER

Principal Investigators

  • Robert Silbergleit, MD · University of Michigan

  • Daniel H Lowenstein, MD · University of California, San Francisco

  • Valerie L Durkalski, PhD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00809146 on ClinicalTrials.gov