Acute severe behavioural disturbance (ASBD) is a medical emergency that can pose a significant risk to the person experiencing it, family members and staff. ASBD is defined as any behaviour including agitation, violence, self-harm or delirium, that can result in a risk of harm to the patient, staff or others and requires treatment to prevent and/or reduce this harm.

ASBD occurs across all age groups, but higher rates are seen in adolescents than in adults.

Acute severe behavioural disturbance (ASBD) is managed following a ‘stepwise’ plan:

• Verbal attempts or comforting measures will first be attempted/offered to de-escalate or calm the young person.
• If medication is deemed necessary, oral medication (meaning, medication that can be taken by mouth) will be offered first.
• If the young person is not willing or not able to accept oral medication and they remain agitated, medication may be provided by injection.

Young persons that meet certain criteria, will be randomly allocated (with a 50:50 chance) to receive a weight-based dose of either oral olanzapine or oral diazepam.

Patients will be observed for one hour from the time a decision is made to provide oral medication. At this time, they will be assessed for the following:

• Successful sedation / reduced agitation (whether the medication was ingested or not)
• Related, possible side effects
• The need for additional sedation
• If harm or damage to ED equipment occurred
• Patient and parent/guardian satisfaction with management.

No follow-up will be required.

Information handouts will be provided when the young person returns to a more regulated state and is able to process information. This handout will contain information about the study, possible side effects of each medication, research staff contact details and instructions on how to withdraw their data (details) from the study if they choose.

Although both medications are widely used for acute severe behavioural disturbance (ASBD) in children around Australia, this is the first study of any type to compare which medication is more effective for the management of paediatric ASBD. The study team believes the trial will significantly advance medical knowledge about the best care for children with ASBD and provide clear information about the occurrence of side effects associated with the medications.

As only single oral doses are being provided in this trial, the study team does not believe that significant risks from either medication will be common.

There is currently no “gold standard” medication for the treatment of paediatric acute severe behavioural disturbance (ASBD). Therefore, whether the medication is randomly assigned or decided by an individual clinician, an increased risk to the young person in comparison with current clinical care is not anticipated.

Additionally, Emergency Department (ED) nursing and medical staff will be aware of which medication the young person is randomly assigned to. If any reactions occur, they will be quickly identified and treated.

No. Management will be the same as current, standard clinical practice. If additional medications or doses to the trial medications are deemed necessary, the Emergency Department (ED) doctor will prescribe these, following hospital-specific guidelines.

A patient is free to withdraw from the study at any time by contacting the study team.