IM Olanzapine Versus Haloperidol or Midazolam
- Conditions
- Acute Agitation, Behavioural Emergency
- Interventions
- Registration Number
- NCT02380118
- Lead Sponsor
- The University of Hong Kong
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 167
- Emergency Department patients, requiring parenteral drug sedation (as determined by an emergency clinician) will be enrolled.
-
Patients will be excluded if there are
- known hypersensitivity or contraindication to the study drugs
- reversible aetiology for agitation (e.g. hypotension, hypoxia, hypoglycaemia)
- known pregnancy
- acute alcohol withdrawal
- patients aged>75 years.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Olanzapine Olanzapine intramuscular olanzapine injection (zyprexa), 5 mg/dose, first dose and an optional second dose. Haloperidol Haloperidol intramuscular haloperidol injection, 5 mg/dose, first dose and an optional second dose. Midazolam Midazolam intramuscular midazolam injection, 5 mg/dose, first dose and an optional second dose.
- Primary Outcome Measures
Name Time Method Time to achieve adequate sedation Within 60 minutes from drug administration Adequate sedation is determined by a 6-point validated scale.
- Secondary Outcome Measures
Name Time Method AED length of stay (LOS) From Emergency Department admission to transfer or discharge from Emergency Department, an expected average of 1 hour 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 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
Trial Locations
- Locations (6)
Pamela Youde Nethersole Eastern Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Prince of Wales Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Ruttonjee Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Tuen Mun Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Queen Mary Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
United Christian Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong