Acute Agitation, Behavioural Emergency
Conditions
Keywords
emergency, emergency medicine, sedation, acute agitation
Brief summary
The purpose of this study is to determine whether oral olanzapine is safer (fewer adverse events) and more effective (shorter time to sedation) than conventional haloperidol or diazepam when used in the management of acute agitation in the emergency.
Detailed description
1. Investigate oral use of sedating drugs within a predominantly Chinese population, to address this void in international literature impacting the management of acute agitation. 2. The multi-centre Randomised Clinical Trial will determine the safety and efficacy of oral olanzapine, in comparison with conventional medicines (haloperidol or diazepam) in a three-arm comparison for the sedation of acutely agitated patients in AEDs. Specifically, we aim to determine if administration of oral olanzapine (a)is more effective than sedation with oral haloperidol or oral diazepam alone; (b)is safer than sedation with comparison arms; (c)decreases the amount of subsequent redosing or alternative drugs required; (d)is more favourable than the haloperidol and diazepam arms with respect to safety, efficacy and adverse events. Investigate potential variables leading to AED attendance and/or admission requiring oral sedation. These may include patient demographic and regular medications and adherence.
Interventions
DRUGOlanzapine oro-dispersible 5Mg Tab
Patient allocated to this arm will be given 5 mg olanzapine oro-dispersible tablet and an encapsulated placebo tablet
DRUGHaloperidol 2Mg encapsulated Tab
Patient allocated to this arm will be given 2 mg encapsulated haloperidol tablet and an oro-dispersible placebo tablet
DRUGDiazepam 2Mg encapsulated Tab
Patient allocated to this arm will be given 2 mg encapsulated diazepam tablet and an oro-dispersible placebo tablet
Sponsors
Queen Elizabeth Hospital, Hong Kong
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Accident & Emergency Department patients * Requiring oral drug sedation (as determined by an emergency clinician) will be enrolled.
Exclusion criteria
* known hypersensitivity or contraindication to the study drugs * reversible aetiology for agitation (e.g. hypotension, hypoxia, hypoglycaemia) * known pregnancy * acute alcohol withdrawal * refusal to take oral medication * patients from correctional facilities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to achieve adequate sedation | Within 60 minutes from drug administration | Adequate sedation is determined by a 6-point validated scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total study drug doses administered; alternative drugs and doses used | From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour | — |
| Corrected QT interval (QTc) | From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour | — |
| AED length of stay (LOS) | From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour | — |
| Adverse events | From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour | including airway management (jaw thrust, oral, nasal airway), need for assisted ventilation (bag/mask, intubation), oxygen desaturation \<90%, systolic BP\<90 mmHg, dystonic reactions, seizures, vomiting or aspiration |
Countries
Hong Kong
Outcome results
None listed