POHCA Resuscitation: Evaluation of IM Epinephrine (PRIME)

Pediatric Out-of-Hospital Cardiac Arrest Resuscitation: Evaluation of IM Epinephrine (The PRIME Trial)

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

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 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 in POHCA.

Paramedic services across Ontario will participate in the study. All sites will begin with a period of baseline data collection (standard of care arm) and will cross over to the intervention arm (Intramuscular Epinephrine Dose arm) on a staggered schedule and in random order. Each site will remain in the intervention arm, once cross over happens, for the duration of the study.

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

POHCA events will be handled per standard of care, however, first dose epinephrine administration will be via intramuscular (IM) autoinjector. Dosing will be dependent on weight as follows: 3-<5kg=0.3mg IM epinephrine 5-<10kg=0.5mg IM epinephrine 10-<25kg=1.0mg IM epinephrine 25kg=1.5mg IM epinephrine

Epinephrine administered via sterile epinephrine injection USP, by 0.3mg or 0.5mg epinephrine auto-injector(s)

The primary outcome will be the time to initial ROSC. The investigator will compare time to initial ROSC between the standard of care and intervention periods.

Time to sustained ROSC will be calculated from the time that paramedics arrive on scene to the time that sustained ROSC, defined as chest compressions not required for 20 minutes with persistent signs of circulation, is achieved.

Survival to emergency department transfer to pediatric critical care unit (PCCU), if applicable: admitted to PCCU from external ED

PCCU and hospital length of stay will be calculated from time of admission to the PCCU/hospital and time to discharge from PCCU/hospital, if applicable, between standard of care and intervention periods

Survival at 6 months and 12 months post-POHCA will be compared between standard of care and intervention periods

The investigator will compare PCPC scores at discharge, 6- and 12-months post-POHCA between the standard of care and intervention periods

Life Impact assessment between 6 and 12 months: the investigator will use the Pediatric Quality of Life (PEDSQoL, Pediatrics Quality of Life) assessment tool at 6- and 12-months post-POHCA in all survivors and compare between standard of care and intervention periods. The score ranges from 0-100, with higher scores indicating better outcome.

Life Impact assessment between 6 and 12 months: the investigator will use the Daily Activities Scale at 6- and 12-months post-POHCA in all survivors and compare between standard of care and intervention periods. This scale is a subscore of the PEDSQoL tool with scores ranging from 0-100, with higher scores indicating better outcome.

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.