Recruiting
Phase 2
Phase 3

Epinephrine

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT05166343

Conditions

Pediatric Out-of-Hospital Cardiac Arrest

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Epinephrine Injection

Study Details

Brief summary:

This is a pragmatic, two-arm, open-label, prospective stepped-wedge cluster quasi randomized control trial (SW-CRCT) looking to evaluate early intramuscular (IM) epinephrine in the management of pediatric out-of-hospital cardiac arrest (POHCA).

Conditions

Pediatric Out-of-Hospital Cardiac Arrest

Study ID

NCT05166343

Start date

Jan 8, 2024

Status verified date

Mar, 2025

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Children aged 1 day to and including 17 years experiencing an out-of-hospital cardiac arrest (OHCA)
  • Must be receiving at least 1 minute of CPR by trained first responders (police, fire, or paramedic services)

Exclusion Criteria:

- Children who experience OHCA due to an obvious traumatic event.

Study Design

Enrollment

284 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Standard of Care

All POHCA events will be handled per standard of care of epinephrine administration via intravenous or intraosseous (IV/IO) based on patient estimated weight.

other: Intramuscular Epinephrine Dose

POHCA events will be handled per standard of care, however, first dose epinephrine administration will be via intramuscular (IM) autoinjector and/or pre-filled syringes. Dosing will be dependent on weight as follows:

  • 3-<5kg=0.3mg IM epinephrine
  • 5-<10kg=0.5mg IM epinephrine
  • 10-<20kg=1.0mg IM epinephrine
  • 20-<30kg=2.0mg IM epinephrine
  • 30kg=3.0mg IM epinephrine

Interventions

Epinephrine Injection

Epinephrine administered via sterile epinephrine injection USP, by 0.3mg or 0.5mg epinephrine auto-injector(s) and/or pre-filled syringe (exact dose).

Primary outcome measure

  • Time to initial return of spontaneous circulation (ROSC) [ Time Frame: At time of event ]

Central Contacts and Locations

Central contacts

Maysaa Assaf

519-685-8500maysaa.assaf@lhsc.on.ca

Locations

Children's Hospital - London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5W9

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Mar 11, 2025

Last verified

Mar, 2025

Keywords

  • cardiac arrest
  • IM Epinephrine
  • standard of care
  • pediatric
  • resuscitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2025-03-11.