None listed
Conditions
Brief summary
Acute severe behavioural disturbance (ASBD) is an emergency situation where a patient experiences severe agitation or aggression. One of the common strategies used to manage those presenting to the emergency department (ED) with ASBD is the provision of medications. Medications assist in allowing the young person to gain control over their behaviour. In most instances, oral medications are used. In individuals less than 18 years of age, there is no evidence available to guide doctors about which medications are the most efficacious, despite them being commonly used to manage ASBD. It is also not known how well these medications are tolerated by young people. Therefore, the primary aim of this study is to determine whether, in children and adolescents with ASBD, oral olanzapine is more effective than oral diazepam at achieving successful sedation (i.e.: a state of calm) at 1 hour after randomisation. These medications were chosen as they are the two most commonly used medication in Australia. This study will be a randomised, open label, multi-centre effectiveness trial which will enrol young people aged 9 to 17 and 364 days presenting to participating EDs with ASBD. We hope to determine which medication is most effective and to assess the side effects of these medications. We hypothesise that 15% more children will achieve successful sedation 1 hour after randomisation to olanzapine compared to those children who were randomised to diazepam.
Interventions
PEAChY-O is a randomised controlled trial which will compare the effectiveness of oral olanzapine [arm one] to oral diazepam [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
PEAChY-O is a randomised controlled trial which will compare the effectiveness of oral olanzapine [arm one] to oral diazepam [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-O study. No modifications to the doses or the medications provided will be allowed. Ingestion in this trial is defined as the young person placing the medication in their mouth with the intent to consume it and the ED clinician deeming that they have ingested either the complete dose or enough to not require additional (or redosing of) medication. Arm One: Participants will receive 5mg olanzapine (sublingual wafer) if they weigh <40kg or 10mg if they weigh 40kg or greater.
Sponsors
Murdoch Children's Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
9 Years to 17 Years
Healthy volunteers
No
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 oral medication is thought to be the most appropriate route of administration.
Exclusion criteria
1. Known, documented or reported allergy or previous serious side effect to either olanzapine or diazepam. 2. Known, documented or reported non-response to either olanzapine or diazepam (e.g. in the medical record, a behavioural management plan [or similar] or by parent / guardian report). 3. Accompanying parent / guardian requests or refuses either olanzapine or diazepam 4. Obvious reversible aetiology for agitation that has been identified and not yet treated (e.g.: hypotension, hypoxia, hypoglycaemia). 5. Known pregnancy. 6. Known long QT syndrome. 7. Participants who have been enrolled in PEAChY-M during this ED admission (previous enrolment is not an exclusion criteria). 8. Participants who have been enrolled in PEAChY-O during a prior ED admission. 9. Clinician decision that alternative route or therapy is more appropriate
Outcome results
None listed