POHCA Resuscitation: Evaluation of IM Epinephrine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-08

Study Completion Date

2029-01-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Pediatric Out-of-Hospital Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type OTHER

Epinephrine Injection

Intervention Type DRUG

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

Interventions

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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).

Intervention Type DRUG

Eligibility Criteria

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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)