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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
284
Epinephrine administered via sterile epinephrine injection USP, by 0.3mg or 0.5mg epinephrine auto-injector(s) and/or pre-filled syringe (exact dose).
Children's Hospital - London Health Sciences Centre
London, Ontario, Canada
RECRUITINGTime to initial return of spontaneous circulation (ROSC)
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 frame: At time of event
Return of spontaneous circulation
Whether return of spontaneous circulation is achieved or not
Time frame: At time of event
Time to sustained ROSC
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.
Time frame: At time of event
Survival
Survival to emergency department transfer to pediatric critical care unit (PCCU), if applicable: admitted to PCCU from external ED
Time frame: From time of event to ED admission
Survival - comparison between both arms
Survival to hospital admission will be compared between standard of care and intervention periods
Time frame: From time of event to hospital admission
PCCU/Hospital length of stay
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
Time frame: From time of hospital/PCCU admission to discharge, up to 1 year
Survival to hospital discharge
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Survival to hospital discharge will be compared between standard of care and intervention periods
Time frame: Dependent on course of hospital stay, up to 1 year
Post POHCA survival
Survival at 6 months and 12 months post-POHCA will be compared between standard of care and intervention periods
Time frame: Dependent on survival at 6 and 12 month period post POHCA event
Neurological status
The investigator will compare PCPC scores at discharge, 6- and 12-months post-POHCA between the standard of care and intervention periods
Time frame: From time of discharge and 6 and 12 months post POHCA event
Life Impact and Pediatric Quality of Life assessments
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.
Time frame: 6 and 12 months post POHCA event
Life Impact and Pediatric Quality of Life assessments
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.
Time frame: 6 and 12 months post POHCA event