IM Olanzapine Versus Haloperidol or Midazolam
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
To address significant knowledge gaps by several means:
- 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.
- Investigate potential variables leading to emergency attendance and/or admission requiring parenteral sedation. These may include patient demographics and regular medications and adherence.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Olanzapine intramuscular olanzapine injection (zyprexa), 5 mg/dose, first dose and an optional second dose. |
Drug: Olanzapine
Intramuscular injection
Other Names:
|
| Active Comparator: Haloperidol intramuscular haloperidol injection, 5 mg/dose, first dose and an optional second dose. |
Drug: Haloperidol
Intramuscular injection
|
| Active Comparator: Midazolam intramuscular midazolam injection, 5 mg/dose, first dose and an optional second dose. |
Drug: Midazolam
Intramuscular injection
|
Outcome Measures
Primary Outcome Measures
- Time to achieve adequate sedation [Within 60 minutes from drug administration]
Adequate sedation is determined by a 6-point validated scale.
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
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
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pamela Youde Nethersole Eastern Hospital | Hong Kong | Hong Kong | ||
| 2 | Prince of Wales Hospital | Hong Kong | Hong Kong | ||
| 3 | Queen Mary Hospital | Hong Kong | Hong Kong | ||
| 4 | Ruttonjee Hospital | Hong Kong | Hong Kong | ||
| 5 | Tuen Mun Hospital | Hong Kong | Hong Kong | ||
| 6 | United Christian Hospital | Hong Kong | Hong Kong |
Sponsors and Collaborators
- The University of Hong Kong
- 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
Investigators
- Principal Investigator: Esther WY Chan, PhD, The University of Hong Kong
Study Documents (Full-Text)
None provided.More Information
Publications
- Chan EW, Knott JC, Taylor DM, Phillips GA, Kong DC. Intravenous olanzapine--another option for the acutely agitated patient? Emerg Med Australas. 2009 Jun;21(3):241-2. doi: 10.1111/j.1742-6723.2009.01190.x.
- Chan EW, Taylor DM, Knott JC, Kong DC. Variation in the management of hypothetical cases of acute agitation in Australasian emergency departments. Emerg Med Australas. 2011 Feb;23(1):23-32. doi: 10.1111/j.1742-6723.2010.01348.x. Epub 2010 Nov 22.
- Chan EW, Taylor DM, Knott JC, Liew D, Kong DC. The pharmacoeconomics of managing acute agitation in the emergency department: what do we know and how do we approach it? Expert Rev Pharmacoecon Outcomes Res. 2012 Oct;12(5):589-95. doi: 10.1586/erp.12.53. Review.
- Chan EW, Taylor DM, Knott JC, Phillips GA, Castle DJ, Kong DC. Intravenous droperidol or olanzapine as an adjunct to midazolam for the acutely agitated patient: a multicenter, randomized, double-blind, placebo-controlled clinical trial. Ann Emerg Med. 2013 Jan;61(1):72-81. doi: 10.1016/j.annemergmed.2012.07.118. Epub 2012 Sep 13.
- Knott JC, Bennett D, Rawet J, Taylor DM. Epidemiology of unarmed threats in the emergency department. Emerg Med Australas. 2005 Aug;17(4):351-8.
- Knott JC, Taylor DM, Castle DJ. Randomized clinical trial comparing intravenous midazolam and droperidol for sedation of the acutely agitated patient in the emergency department. Ann Emerg Med. 2006 Jan;47(1):61-7. Epub 2005 Aug 18.
- PR/CT 0309/2014 (SC)
- HKU 789813M