RecruitingPHASE2, PHASE3INTERVENTIONAL

POHCA Resuscitation: Evaluation of IM Epinephrine

This study is investigating a new way to give adrenaline (epinephrine) to children who experience a sudden heart stop outside of the hospital, often called a cardiac arrest. Doctors usually give this medicine into a vein or bone, but this can take time. This study is testing if giving adrenaline quickly into a muscle, like with an auto-injector, might be better. The main goal is to see if this faster way of giving the medicine can improve how well children recover, both in the short term and over time, without causing more harm. While adrenaline injections are already used for other serious conditions, this is the first time it's being specifically looked at for children with a sudden heart stop.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

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

Enrolment target

284

Start

08 Jan 2024

Estimated completion

01 Jan 2029

Pediatric Out-of-Hospital Cardiac Arrest

What is this study about?

Imagine a child has a sudden medical emergency where their heart unexpectedly stops working outside of a hospital, perhaps at home or in a public place. This is called a pediatric out-of-hospital cardiac arrest (POHCA). When this happens, every second counts, and doctors try to give medicines like adrenaline (sometimes called epinephrine) as quickly as possible.

Currently, adrenaline is usually given into a vein or directly into the bone, which can sometimes be a difficult or slow process in an emergency. This study is exploring a different approach: giving adrenaline quickly into a muscle, similar to how people with severe allergies might use an auto-injector for adrenaline. The researchers want to find out if this quicker way of giving the first dose of adrenaline can make a real difference to these children's chances of survival and recovery.

The main aim is to see if giving adrenaline into a muscle can lead to faster administration of the medicine, and if this helps the heart start beating again sooner. They also want to understand if this method improves the child's recovery in the long run, and importantly, if it is as safe as current methods. This is an important trial because while we know a lot about adrenaline injections for other conditions, we don't yet have enough information about its use in this specific emergency for children.

Key takeaways

This study is about giving adrenaline into a muscle for children having a sudden heart stop.
It aims to see if this faster method improves recovery.
The study focuses on children aged 1 day to 17 years.
It's the first study of its kind for this specific emergency.

Who may be eligible?

This study is for children who experience a sudden heart stop outside of the hospital. To be included, the child must be between 1 day old and 17 years old. They also need to be receiving chest compressions (CPR) from trained emergency responders, like paramedics, police, or firefighters, for at least one minute.

Children who had a sudden heart stop because of a clear physical injury, like from a serious accident, would not be included in this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is the child aged between 1 day and 17 years?
Did the child experience a sudden heart stop outside of a hospital?
Was the child receiving CPR from trained emergency services?
Was the heart stop NOT caused by a physical injury (like an accident)?

Answer every question to see your result.

What does participation involve?

As this study involves an emergency situation, consent for participation might be obtained differently than a typical study. If a child meets the criteria, they might receive adrenaline into a muscle as part of their emergency care. Doctors will then collect information about their treatment and recovery. There won't be extra visits for the family specifically because of the study. All medical assessments and follow-up care will be part of the child's standard emergency and ongoing medical treatment. The study will look at the information from these treatments to understand the effectiveness of an adrenaline injection given into a muscle.

Potential risks and benefits

There is a potential benefit that giving adrenaline quickly into a muscle might help a child's heart start beating sooner and improve their overall recovery after a sudden heart stop. However, as with any medical treatment, there can be potential risks, though adrenaline is a commonly used medication in emergencies. The medical team will always act in the child's best interest. If you are a parent or guardian and a child under your care might be involved, you would have the right to discuss any concerns and potentially withdraw from the study at any point, without affecting the child's medical care.

Locations (1)

Children's Hospital - London Health Sciences Centre
Verified postcode
London, Canada· Recruiting

Common questions

What is 'pediatric out-of-hospital cardiac arrest'?

It means when a child's heart suddenly stops beating outside of a hospital setting, such as at home or in school.

What is adrenaline (epinephrine)?

It's a powerful medicine that can help restart the heart and support blood pressure during a medical emergency.

Why a muscle injection instead of a vein?

Giving medicine into a muscle can often be done much faster, which is very important in emergencies where every second counts.

Will my child automatically be in the study if this happens?

If your child meets the study criteria and it's an emergency, they may receive treatment as part of the study. You would then be given more information.

Will my child get the best care regardless of the study?

Absolutely, all children will receive the best possible emergency medical care, whether they are part of the study or not.

How to find out more

Maysaa Assaf

maysaa.assaf@lhsc.on.ca 519-685-8500 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.