POHCA Resuscitation: Evaluation of IM Epinephrine (PRIME)

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

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Pediatric Out-of-Hospital Cardiac Arrest

Treatments: Drug: Epinephrine Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05166343

PRIME-1

Details and patient eligibility

About

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).

Full description

IM epinephrine may provide a more efficient means of administering the initial epinephrine dose (versus IV/IO administration) to a child experiencing pediatric out of hospital cardiac arrest (POHCA) with no greater risk of harm. In so doing, this may improve the short- and long-term outcomes of these patients. There is an abundance of literature detailing the risk/benefit profile of IM epinephrine use in anaphylaxis; however, there is no human data on this topic as it relates to cardiac arrest. Important knowledge gaps include whether the use of IM epinephrine via autoinjector and/or pre-filled syringe leads to faster administration of the initial doses of epinephrine without delaying time to definitive epinephrine (via IV/IO) and the impact on time to initial and sustained return of spontaneous circulation (ROSC). This trial will be the first to examine the role of IM epinephrine via autoinjector/pre-filled syringe in POHCA.

Enrollment: 284 estimated patients

Sex: All

Ages: 1 day to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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284 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

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

Intramuscular Epinephrine Dose

Other group

Description:

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

Treatment:

Drug: Epinephrine Injection