Pediatric Dose Optimization for Seizures in Emergency Medical Services

PHASE3RecruitingINTERVENTIONAL
Enrollment

6,700

Participants

Timeline

Start Date

August 8, 2022

Primary Completion Date

July 31, 2026

Study Completion Date

September 30, 2026

Conditions
Seizures
Interventions
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).

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)."

Trial Locations (20)

14203

RECRUITING

University at Buffalo, Buffalo

15224

RECRUITING

University of Pittsburgh, Pittsburgh

20010

RECRUITING

Children's National Hospital, Washington D.C.

28226

RECRUITING

Mecklenburg EMS, Charlotte

30322

RECRUITING

Emory University, Atlanta

43205

RECRUITING

Nationwide Children's Hospital, Columbus

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

RECRUITING

Indiana University, Indianapolis

48105

RECRUITING

University of Michigan, Ann Arbor

53226

RECRUITING

Medical College of Wisconsin, Milwaukee

75235

RECRUITING

University of Texas Southwestern, Dallas

77030

RECRUITING

Baylor College of Medicine, Houston

80045

RECRUITING

University of Colorado, Aurora

84108

RECRUITING

University of Utah, Salt Lake City

85724

RECRUITING

University of Arizona, Tucson

90027

RECRUITING

Children's Hospital of Los Angeles, Los Angeles

94143

RECRUITING

University of California, San Francisco, San Francisco

95817

RECRUITING

University of California, Davis, Sacramento

97239

RECRUITING

Oregon Health and Sciences University, Portland

98104

RECRUITING

University of Washington, Seattle

All Listed Sponsors
collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

collaborator

University of Utah

OTHER

collaborator

Baylor College of Medicine

OTHER

lead

Stanford University

OTHER