Acute Agitation, Behavioural Emergency
Conditions
Keywords
emergency, emergency medicine, sedation, acute agitation
Brief summary
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.
Detailed description
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.
Interventions
DRUGOlanzapine
Intramuscular injection
DRUGHaloperidol
Intramuscular injection
DRUGMidazolam
Intramuscular injection
Sponsors
Queen Mary Hospital, Hong Kong
Tuen Mun Hospital
Pamela Youde Nethersole Eastern Hospital
Ruttonjee Hospital
Prince of Wales Hospital, Shatin, Hong Kong
United Christian Hospital
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
* Emergency Department patients, requiring parenteral drug sedation (as determined by an emergency clinician) will be enrolled.
Exclusion criteria
* Patients will be excluded if there are 1. known hypersensitivity or contraindication to the study drugs 2. reversible aetiology for agitation (e.g. hypotension, hypoxia, hypoglycaemia) 3. known pregnancy 4. acute alcohol withdrawal 5. patients aged\>75 years.
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 Emergency Department admission to transfer or discharge from AED, an expected average of 1 hour | — |
| Prolonged QTc interval | From Emergency Department admission to transfer or discharge from Emergency Department, an expected average of 1 hour | — |
| AED length of stay (LOS) | From Emergency Department admission to transfer or discharge from Emergency Department, an expected average of 1 hour | — |
| Adverse events | From Emergency Department admission to transfer or discharge from Emergency Department 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