Seizure Medication Dosing Protocol: The PediDOSE Study – Phase III

Pediatric Dose Optimization for Seizures in EMS (PediDOSE)

Protocol Description

The purpose of this multi-center research study is to determine if an age-based dosing protocol can improve outcomes for children having life-threatening seizures when treated by emergency medical service (EMS) personnel. Midazolam is a proven treatment that paramedics already use to stop a seizure, but sometimes delays occur as they perform multi-step calculations to determine the dose or try to insert an intravenous (IV) line into a seizing child. These delays can result in children receiving an underdose of medication, with as many as one third arriving via ambulance at a hospital’s emergency department still seizing. The PediDOSE trial evaluates an age-based, calculation-free method that can expedite administration of midazolam via intranasal or intramuscular routes.

Study Level: Phase III

Eligibility Criteria

Children, ages of 6 months through 13 years who are experiencing an ongoing seizure, may be treated according to the new standardized plan by responding City of Pittsburgh paramedics trained in use of the new protocol.
Boys and Girls: Ages 6 months through 13 years

Requirements

Participating EMS responders will replace the current weight-based protocol for calculating the midazolam dose with the new standardized age category treatment protocol in selected intervals over a 4-year period. Based on age, seizing children will be treated with a pre-determined midazolam dose via nasal spray or intramuscular injection, rather than via IV infusion. Following the patient’s arrival at the Emergency Department of UPMC Children’s Hospital, researchers will collect treatment data to compare results of the new standardized plan to results of those treated using the current protocol.
Visits: 1, the initial Emergency Department visit
Duration: Not Applicable

Status: Enrollment Pending

Source(s) of Support

National Institute of Neurological Disorders and Stroke
National Institutes of Health

Primary Investigator

Sylvia Owusu-Ansah, MD

Contact Information

For more information about the study, please contact:
Clinical Research Manager Shanon Young, MSN, RN, CPEN
412-692-6567