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Evaluating intramuscular epinephrine in pediatric out-of-hospital cardiac arrest (the PRIME trial): study protocol
Samina Idrees1,2, Maysaa Assaf1,2, Matthew Davis3,4
1Children's Health Research Institute, London Health Sciences Centre, London, ON, Canada.
Insights
Intramuscular epinephrine may improve return of spontaneous circulation (ROSC) in pediatric out-of-hospital cardiac arrest (POHCA). The PRIME trial investigates if this method offers faster ROSC compared to standard care for POHCA resuscitation.
Area of Science:
- Emergency Medicine
- Pediatric Critical Care
- Cardiovascular Research
Background:
- Pediatric out-of-hospital cardiac arrest (POHCA) has a high mortality rate, necessitating rapid and effective resuscitation.
- Current guidelines recommend intravenous (IV) or intraosseous (IO) epinephrine, but vascular access can be difficult in pediatric emergencies.
- Intramuscular (IM) epinephrine, used in anaphylaxis, bypasses the need for vascular access, potentially reducing time to medication delivery.
Purpose of the Study:
- To evaluate the impact of initial intramuscular (IM) epinephrine administration on pediatric out-of-hospital cardiac arrest (POHCA) outcomes.
- To determine if IM epinephrine improves the time to return of spontaneous circulation (ROSC) compared to standard care.
- To assess the effects of IM epinephrine on survival to hospital discharge and neurological outcomes.
Main Methods:
- Prospective, multi-centre, pragmatic, two-arm, open-label, stepped-wedge cluster quasi-randomized controlled trial (PRIME trial).
- Randomization at the paramedic service level, with each site serving as its own control.
- Primary outcome is time to ROSC; secondary outcomes include survival and neurological function at discharge.
Main Results:
- This section is not available in the provided abstract.
- Further analysis is required to determine the primary outcome (time to ROSC) and secondary outcomes.
Conclusions:
- The PRIME trial will provide crucial data on the effectiveness and safety of IM epinephrine for POHCA.
- Findings have the potential to influence resuscitation guidelines and improve care for pediatric cardiac arrest patients.
- The study aims to optimize emergency medical services' response to POHCA through innovative drug delivery methods.
Background:
Pediatric out-of-hospital cardiac arrest (POHCA) is a time-sensitive event with a high mortality rate. Epinephrine is a key first-line medication used during cardiac arrest resuscitation to support perfusion and return of spontaneous circulation (ROSC). Guidelines for the management of POHCA recommend paramedics administer epinephrine as soon as possible by intravenous (IV) or intraosseous (IO) injection. However, successfully inserting an IV or IO line can be challenging in high-stress situations, particularly in a poorly perfused, small child. In contrast, intramuscular (IM) epinephrine, which is the standard of care in anaphylaxis management, does not require paramedics to secure vascular access and may lead to a shorter time to first dose. The POHCA Resuscitation: Evaluation of IM Epinephrine (PRIME) trial aims to evaluate the impact of IM epinephrine on POHCA outcomes. The primary objective of the PRIME trial is to determine if an initial dose of IM epinephrine improves time to return of spontaneous circulation (ROSC) compared to standard of care alone.
Methods:
The PRIME trial is a prospective, multi-centre, pragmatic, two-arm, open-label, stepped-wedge cluster quasi-randomized controlled trial. We will randomize at the level of the paramedic service, as individual-level randomization is not possible due to the inclusion of multiple, heterogeneous regions. Each site will serve as its own control. This study is a regional trial, with a focus on limited efficacy testing through an intermediate outcome (i.e., time to ROSC) that is strongly associated with survival. We also aim to evaluate the impact of the intervention on survival to hospital discharge, survival to hospital discharge with favourable neurological outcome, and safety in POHCA management.
Discussion:
The PRIME trial aims to provide insight into the effectiveness and safety of IM epinephrine in POHCA. The data and analyses generated from the trial have the potential to inform resuscitation guidelines and standard of care practices.
Trial Registration:
ClinicalTrials.gov NCT05166343, Registered on December 8, 2021.
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