Pediatric Dose Optimization for Seizures in Emergency Medical Services (PediDOSE)

September 26, 2025 updated by: Manish Shah, Stanford University

Pediatric Dose Optimization for Seizures in EMS (PediDOSE)

The Pediatric Dose Optimization for Seizures in Emergency Medical Services (PediDOSE) study is designed to improve how paramedics treat seizures in children on ambulances. Seizures are one of the most common reasons why people call an ambulance for a child, and paramedics typically administer midazolam to stop the seizure. One-third of children with active seizures on ambulances arrive at emergency departments still seizing. Prior research suggests that seizures on ambulances continue due to under-dosing and delayed delivery of medication. Under-dosing happens when calculation errors occur, and delayed medication delivery occurs due to the time required for dose calculation and placement of an intravenous line to give the medication. Seizures stop quickly when standardized medication doses are given as a muscular injection or a nasal spray. This research has primarily been done in adults, and evidence is needed to determine if this is effective and safe in children.

PediDOSE optimizes how paramedics choose the midazolam dose by eliminating calculations and making the dose age-based. This study involves changing the seizure treatment protocols for ambulance services in 20 different cities, in a staggered and randomly-assigned manner.

One aim of PediDOSE is to determine if using age to select one of four standardized doses of midazolam and giving it as a muscular injection or nasal spray is more effective than the current calculation-based method, as measured by the number of children arriving at emergency departments still seizing. The investigators believe that a standardized seizure protocol with age-based doses is more effective than current practice.

Another aim of PediDOSE is to determine if a standardized seizure protocol with age-based doses is just as safe as current practice, since either ongoing seizures or receiving too much midazolam can interfere with breathing. The investigators believe that a standardized seizure protocol with age-based doses is just as safe as current practice, since the seizures may stop faster and these doses are safely used in children in other healthcare settings.

If this study demonstrates that standardized, age-based midazolam dosing is equally safe and more effective in comparison to current practice, the potential impact of this study is a shift in the treatment of pediatric seizures that can be easily implemented in ambulance services across the United States and in other parts of the world.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

6700

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
    • California
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Children's Hospital of Los Angeles
        • Contact:
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California, Davis
        • Contact:
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Contact:
    • Colorado
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Contact:
          • Gregory W Faris, MD
          • Phone Number: 317-962-3886
          • Email: gfaris@iu.edu
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Recruiting
        • University of Michigan
        • Contact:
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • University at Buffalo
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 28226
        • Recruiting
        • Mecklenburg EMS
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
      • Columbus, Ohio, United States, 43205
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Sciences University
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • University of Pittsburgh
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75235
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84108
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • University of Washington
        • Contact:
          • Andrew Latimer, MD
          • Phone Number: 206-521-1588
          • Email: alatim@uw.edu
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 13 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Witnessed by the paramedic to be actively seizing, regardless of seizure type or duration; AND
  • Under the care of a paramedic; AND
  • Transported by an EMS agency participating in the study

Exclusion Criteria:

  • A prior history of a benzodiazepine allergy; OR
  • Known or presumed pregnancy; OR
  • Severe growth restriction based on the paramedic's subjective assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
This arm will be exposed to the study intervention: a standardized seizure protocol.
Drug: Standardized seizure protocol
The intervention is a standardized seizure protocol for paramedics that prioritizes administration of only intramuscular (IM) or intranasal (IN) midazolam, up to 2 doses given 5 minutes apart, with age-based dosing as follows: 6-16 months (1.25 mg); 17 months-5 years (2.5 mg); 6-11 years (5 mg); 12-13 years (10 mg).
Other Names:
  • midazolam
Active Comparator: Control
This arm will be exposed to the emergency medical services (EMS) agency's existing seizure protocol; this is the control arm
Drug: Conventional seizure protocol

The control is the EMS agency's current seizure protocol, based on conventional calculation-based dosing. These vary from one EMS agency to the other with respect to recommended midazolam doses ranging from 0.05-0.3 mg/kg and with multiple route choices listed, including intravenous, intraosseous, intramuscular, intranasal, and rectal.

for paramedics that prioritizes administration of only intramuscular (IM) or intranasal (IN) midazolam, up to 2 doses given 5 minutes apart, with age-based dosing as follows: 6-16 months (1.25 mg); 17 months-5 years (2.5 mg); 6-11 years (5 mg); 12-13 years (10 mg).

Other Names:
  • midazolam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seizing on emergency department arrival
Time Frame: Between arrival to the emergency department and 10 minutes after arrival
Binary assessment of whether the participant is seizing or not upon arrival to the emergency department, as measured by either a rapid response electroencephalogram (preferred) or clinical judgement (alternative).
Between arrival to the emergency department and 10 minutes after arrival

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory failure
Time Frame: Between paramedic arrival on scene until 30 minutes after emergency department arrival
A binary assessment of insufficient breathing at any point during EMS care or within 30 minutes of emergency department arrival, defined as having received bag valve mask ventilation, bi-level positive airway pressure, placement of a supraglottic airway or endotracheal intubation.
Between paramedic arrival on scene until 30 minutes after emergency department arrival
Time to first midazolam administration
Time Frame: From paramedic arrival to the scene until emergency department arrival, assessed up to 1 hour after paramedic scene arrival or 1 minute after emergency department arrival, whichever occurs last
Time in minutes from paramedic arrival to the scene until the paramedic administers midazolam to the patient
From paramedic arrival to the scene until emergency department arrival, assessed up to 1 hour after paramedic scene arrival or 1 minute after emergency department arrival, whichever occurs last

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to seizure cessation in the emergency department
Time Frame: From emergency department arrival until emergency department departure, assessed up to 24 hours after emergency department arrival
For participants who are seizing upon emergency department arrival, this is the time in minutes that it takes for the seizure to stop, as determined by the rapid response electroencephalogram (preferred) or clinical judgement (alternative)
From emergency department arrival until emergency department departure, assessed up to 24 hours after emergency department arrival
Dose/route adherence
Time Frame: From paramedic arrival to the scene until emergency department arrival, assessed up to 1 hour after paramedic scene arrival or 1 minute after emergency department arrival, whichever occurs last
A binary assessment of receiving midazolam in the prehospital setting by both the preferred route (intranasal or intramuscular) and correct dose [within 30% of 0.2 mg/kg (=0.14-0.26 mg/kg)], based on a calculation from weight measured in the emergency department
From paramedic arrival to the scene until emergency department arrival, assessed up to 1 hour after paramedic scene arrival or 1 minute after emergency department arrival, whichever occurs last
Life-threatening hypotension
Time Frame: Between paramedic midazolam administration and hospital discharge, assessed up to 24 hours
A binary assessment of whether or not the patient had a systolic blood pressure in mm Hg that persisted below the following age-based thresholds despite receiving a 20 ml/kg isotonic fluid bolus: 6-11 months (<60 mm Hg); 1-10 years {< [(age in years)x2] + 70 mm Hg}; >10 years: (<90 mm Hg)
Between paramedic midazolam administration and hospital discharge, assessed up to 24 hours
Life-threatening cardiac arrhythmia
Time Frame: Between paramedic midazolam administration and hospital discharge, assessed up to 24 hours
A binary assessment of whether or not the patient's heart rhythm changed to require intervention with chest compressions, pacing, defibrillation, or the use of an anti-arrhythmic agent or procedure.
Between paramedic midazolam administration and hospital discharge, assessed up to 24 hours
Depressed level of consciousness
Time Frame: Between paramedic midazolam administration and 4 hours after emergency department arrival
Glasgow coma score <8 that persists more than 4 hours after emergency department arrival
Between paramedic midazolam administration and 4 hours after emergency department arrival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Baylor College of Medicine
National Institute of Neurological Disorders and Stroke (NINDS)
University of Utah

Investigators

  • Principal Investigator: Manish I Shah, MD, MS, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2022

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

October 26, 2021

First Submitted That Met QC Criteria

November 4, 2021

First Posted (Actual)

November 16, 2021

Study Record Updates

Last Update Posted (Estimated)

September 30, 2025

Last Update Submitted That Met QC Criteria

September 26, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 73018
  • BCM H-49824 (Other Identifier: Baylor College of Medicine)
  • U01NS114042 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After subject enrollment and follow up have been completed, the Data Coordinating Center (DCC) for the study will prepare a final study database for analysis. A releasable database will be produced and completely de-identified in accordance with the definitions provided in the Health Insurance Portability and Accountability Act (HIPAA). Namely, all identifiers specified in HIPAA will be recoded in a manner that will make it impossible to deduce or impute the specific identity of any participant. The database will not contain institutional identifiers.

The DCC will also prepare a data dictionary that provides a concise definition of every data element included in the database. If specific data elements have idiosyncrasies that might affect interpretation or analysis, this will be discussed in the dictionary document. In accordance with policies determined by the investigators and funding sponsors, the releasable database will be provided to users in electronic form.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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