Pharmacological Emergency management of Agitation in Children and Young People – randomised controlled trials of Oral and intraMuscular medication: PEAChY-O and PEAChY-M

Acute severe behavioural disturbance (ASBD) is an emergency situation where a patient experiences severe agitation or aggression. These individuals commonly present to the emergency department (ED) for treatment. Medications are often provided to assist the person to feel calmer. In most instances, oral medications are used. When the patient is extremely agitated, an intramuscular (IM) injection will be given.

In individuals less than 18 years, there is minimal available evidence to guide doctors about which medications work best. It is also not known how well these medications are tolerated by these young people. Therefore, the PREDICT (Paediatric Research in Emergency Departments International Collaborative) network is running two trials across a number of Australian EDs to create evidence to be used to guide the treatment for these young people.

The first study (PEAChY-O) compares two oral medications - olanzapine and diazepam - to determine which medication works better. The second study (PEAChY-M) compares two IM medications – olanzapine and droperidol. These medications were chosen because they are used as standard of care in Australian EDs and are recommended on current Clinical Practice Guidelines (CPGs). These are important studies because they will be the first trials to compare any medications head-to-head in a randomised trial across either the oral or IM routes.
Once the results are available, they will be used to guide future clinical practice including influencing the recommendations made in Australian guidelines, ensuring that these young people receive evidence-based treatments.

Kids THRIVE

When a child presents to an emergency department, or is admitted to the intensive care unit because of a life-threatening condition, they may need immediate treatment to support their breathing. In these circumstances a child is given medication to put them to sleep and the airway is secured with the insertion of a tube into the windpipe. This transition from spontaneous breathing when a child is awake to controlled respiration under anaesthetic via a breathing tube is called intubation. This procedure is technically challenging and is often associated with low oxygen levels in children.

New methods of intubation which reduce the risk of oxygen levels becoming low are continually developed and safely tested through clinical trials. The Trans-nasal Humidified Rapid Insufflation Ventilatory Exchange in children requiring emergency intubation (Kids THRIVE) is one of these clinical trials. In this study, we investigated a new approach to prevent a drop in oxygen levels during intubation using high flow oxygen delivery. We tested this method in children with healthy lungs undergoing anaesthesia for elective surgery and we found that we can maintain oxygen levels more than twice as long as using standard intubation methods. These findings would allow the operator in emergency settings more time and a safer condition to secure the airway in a sick child.

By comparing the current standard practice for intubating a child in an emergency situation, we aim to demonstrate that the THRIVE method will reduce the risk for low oxygen levels in the blood and increase the likelihood that the treating doctor is able to insert the breathing tube on the first attempt.

ConSEPT: Convulsive Status Epilepticus Paediatric Trial

Convulsive Status Epilepticus (CSE) is the most common childhood neurological emergency, sometimes resulting in death or serious disability. CSE is managed with anticonvulsant medications in a step-wise approach until seizures stop. While some management strategies for CSE are well supported by evidence (e.g. initial administration of benzodiazepines), subsequent strategies are based on expert consensus and not evidence. Phenytoin, the traditional second line agent for CSE has a high failure rate, causes adverse events and must be administered slowly. Levetiracetam, a newer anticonvulsant, has a favourable adverse events profile, can be administered quickly and has good efficacy for various seizure types.

This research project proposes to undertake a randomised controlled trial of the second line anticonvulsants phenytoin and levetiracetam for CSE in children. This multi-centre study was a world first and is likely to have a profound impact on the management of CSE in children in New Zealand, Australia and worldwide, in either confirming the current second line medication used or recommending a newer second line medication.

The Australasian Paediatric Head Injury Rules: a prospective validation of 3 international clinical decision rules for acute head injury in children presenting to emergency departments.

Many children sustain head injuries and present to emergency departments for evaluation. Even a seemingly minor incident may lead to serious injury requiring neurosurgery. While head computer tomography (CT) identifies all important injuries, there is an increasing recognition that radiation from CTs can increase the risk of fatal brain cancers, especially in younger children.

Failure to identify a significant intracranial injury quickly may result in catastrophic consequences including long-term neurological disability and or death. A number of evidence-based head injury (HI) clinical decision rules (CDRs) have been developed to help physicians identify patients at risk of having a significant head injury. These CDRs provide recommendations (including CTs) based on the presence of certain features of the history or physical examination. No HI CDRs have been validated outside of their original settings.

The identification of an optimal CDR for implementation would help to minimise risks, both of missing a clinically significant intracranial injury, and of exposure to radiation from cranial CT scans. The results will likely have a major impact on head injury management in children in Australia, New Zealand and worldwide.