The purpose of this study is to determine whether intramuscular olanzapine is safer (fewer adverse events) and more effective (shorter time to sedation) than conventional haloperidol or midazolam when used in the management of acute agitation in the emergency department.
To address significant knowledge gaps by several means: 1. Investigate intramuscular use of sedative drugs within a predominantly Chinese population, to address this void in international literature impacting the management of acute agitation. The multi-centre RCT will determine the safety and efficacy of intramuscular olanzapine, in comparison with conventional medicines (haloperidol or midazolam) in a three-arm comparison for the sedation of acutely agitated patients in emergency department. Specifically, we aim to determine if administration of intramuscular olanzapine (a)is more effective than sedation with intramuscular haloperidol or intramuscular midazolam 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 midazolam arms with respect to safety, efficacy and adverse events. 2. Investigate potential variables leading to emergency attendance and/or admission requiring parenteral sedation. These may include patient demographics and regular medications and adherence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
167
Intramuscular injection
Intramuscular injection
Intramuscular injection
Pamela Youde Nethersole Eastern Hospital
Hong Kong, Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Ruttonjee 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 Emergency Department admission to transfer or discharge from AED, an expected average of 1 hour
Prolonged QTc interval
Time frame: From Emergency Department admission to transfer or discharge from Emergency Department, an expected average of 1 hour
AED length of stay (LOS)
Time frame: From Emergency Department admission to transfer or discharge from Emergency Department, 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 Emergency Department admission to transfer or discharge from Emergency Department an expected average of 1 hour
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Tuen Mun Hospital
Hong Kong, Hong Kong
United Christian Hospital
Hong Kong, Hong Kong