PEAChY-M

INTERVENTION: PEAChY‐M is a randomised controlled trial which will compare the effectiveness of intramuscular (IM) olanzapine [arm one] to IM droperidol [arm two] for the management of paediatric acute severe behavioural disturbance occurring in the emergency department (ED). ASBD will be determined by confirming the participant has a Sedation Assessment Tool (SAT) score of +1 or greater. Dosing will be based on weight. This is an open label study. The trial medication will be provided by the clinical staff caring for the participant in the ED. Only one dose will be provided as part of the PEAChY‐M study. No modifications to the doses or the medications provided will be allowed. Arm One: Participants will receive 5mg IM olanzapine if they weigh <40kg or 10mg if they weigh 40kg or greater. CONDITION: acute severe behavioural disturbance; ; acute severe behavioural disturbance Emergency medicine ‐ Other emergency care PRIMARY OUTCOME: The primary outcome will be successful sedation without the requirement for additional sedation 1 hour post randomisation.; Successful sedation will be assessed using the Sedation Assessment Tool Score.[1 hour post randomisation.] SECONDARY OUTCOME: Clinician assessment of whether “successful sedation” was achieved. ; This will be assessed at 1 hour post randomisation. ; In addition to the objective primary outcome, this will provide the clinician caring for the participant the opportunity to provide a binary assessment of whether they believe successful sedation has been achieved using a yes/no scale.[Measured at the time of the primary outcome (1 hour post randomisation).] Disposition upon discharge from the ED. ; For example: discharged home or admitted to a mental health unit. ; ; The participant's medical record will be reviewed to determine their disposition upon discharge from the ED.[Measured at the time the participant is discharged from the ED.] Further episodes of violent and acute behavioural disturbance in the ED after randomisation until discharge from the ED. ; ; The participant's medical records will be reviewed retrospectively by research staff to determine if any further episodes of violence or behavioural disturbance were noted.[From randomisation until the participant leaves the ED.] Healthcare resource use and costs incurred from time of randomisation until ED discharge. ; ; The use and costs incurred will be determined through an audit of the participant's medical records to assist in determining the following factors: ; number of ED staff members involved in the participant's care ; the participant's length of stay in ED ; amount of time requiring high‐dependency care in the ED ; cost of medication provided ; cost related to damage to property and/or ED equipment ; cost of the participant's hospital stay ; cost of associated side effects or adverse events experienced[Measured from the time of randomisation until the participant is discharged from the ED.] Healthcare resource use and costs incurred from time of randomisation until hospital discharge. ; ; The use and costs incurred will be determined through an audit of the participant's medical records to assist in determining the following factors: ; number of ED staff members involved in the participant's care ; amount of time requiring high‐dependency care in the ED ; cost of medication provided ; cost related to damage to property and/or ED equipment ; the participant's length of stay in the hospital ; cost of the participant's hospital stay ; cost of associated side effects or adverse events experienced whilst in the hospital[Measured from the time of randomisation until the participant is discharged from the hospital. ; ] Injuries to participants and/or their parents or guardians from randomisation until the participant's discharge from the ED. ; For example: injuries related to physical or mechanical restraints inclusive of skin erythema or bruising. ; ; The participant's medical records will be reviewed retrospectively by research staff to determine if any injuries to participants and/or their parents or guardians were documented.[From randomisation until the participant leaves the ED.] Injuries to staff from randomisation until the participant's discharge from the ED. ; For example: soft tissue injuries sustained from being punched or kicked. ; ; The participant's medical records will be reviewed retrospectively by research staff to determine if any injuries to staff were documented. Research staff will also review the hospital's incident management recording system to identify if any injuries were reported during the participant's ED stay.[From randomisation until the participant leaves the ED.] Length of stay in hospital (from the time of randomisation). ; ; The participant's medical record will be reviewed to determine the time at which the participant was discharged from the hospital. ; Note: this will only apply to participants who were admitted to the hospital.[From the time of randomisation until the participant leaves the hospital.] Length of stay in the ED (from the time of randomisation). ; ; The participant's medical record will be reviewed to determine the time at which the participant was discharged from the ED.[From randomisation until the participant leaves the ED.] Medication related adverse events reported from after the measurement of the primary outcome until the participant is discharged from hospital. ; ; The participant's medical record will be reviewed retrospectively by research staff to determine if any adverse events were noted during the time period specified.[From 1 hour post randomisation (immediately after measurement of primary outcome) until the participant is discharged from hospital.] Medication related adverse events reported from randomisation until measurement of the primary outcome. ; ; Medication related adverse events will be recorded on prospective case report forms by clinical staff and the participant's medical record will be reviewed retrospectively by research staff to determine if any adverse events were noted during the time period specified.[From randomisation until the primary outcome is measured (1 hour following randomisation).] Staff, participant and carer satisfaction with the management provided after 1 hour post randomisation but before the participant is discharged from the ED. ; ; A satisfaction survey will be provided to each of the three groups outlined above. This survey will assess how satisfied the staff member, participant and/or carer was with how the medication provided helped them feel calm, how fast it worked and how well it was tolerated on a three point Likert Scale.[To be assessed as soon as practical after the primary outcome measurement is undertaken but must be measured before the participant is discharged from ED.] To describe the length of stay in the ED (from time of triage). ; ; ; ; ; This information will be documented on the prospective case report form by clinical staff.[Measured at 1 hour post randomisation.] INCLUSION CRITERIA: 1. Age between 9 years and 17 years and 364 days. 2. SAT score of +1 or greater as determined by the ED clinician (i.e. patient deemed to be in a state of ASBD). 3. Concerted attempts at non‐pharmacological management of the participant’s ASBD have failed. 4. ED clinician determines that medication is required to assist with management of the participant’s ASBD and IM medication is thought to be the most appropriate route of administration. ; The participant's medical record will be reviewed and this information will be captured retrospectively by research staff. [From time of triage until the participant is discharged from the ED.] To describe the length of stay in the hospital (from time of triage). ; The participant's medical record will be reviewed and this information will be captured retrospectively by research staff. [From time of triage until the participant is discharged from hospital. ] Whether a participant is administered their prescribed weight‐based dose or not. ; This information will be documented on the prospective case report form by clinical staff. In addition, the participant's medical record will be reviewed to determine the dose provided.[Measured at 1 hour post randomisation.] Whether a participant is administered their randomised medication or not.