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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
12
Patient allocated to this arm will be given 5 mg olanzapine oro-dispersible tablet and an encapsulated placebo tablet
Patient allocated to this arm will be given 2 mg encapsulated haloperidol tablet and an oro-dispersible placebo tablet
Patient allocated to this arm will be given 2 mg encapsulated diazepam tablet and an oro-dispersible placebo tablet
Queen Elizabeth Hospital
Hong Kong, Hong Kong
Time to achieve adequate sedation
Adequate sedation is determined by a 6-point validated scale
Time frame: Within 60 minutes from drug administration
Total study drug doses administered; alternative drugs and doses used
Time frame: From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour
Corrected QT interval (QTc)
Time frame: From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour
AED length of stay (LOS)
Time frame: From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour
Adverse events
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
Time frame: From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.