Acute Agitation, Behavioural Emergency Clinical Trial
Official title:
Intramuscular Olanzapine Versus Haloperidol or Midazolam for the Management of Acute Agitation in the Emergency Department - a Multicentre Randomised Clinical Trial
| Verified date | November 2022 |
| Source | The University of Hong Kong |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 167 |
| Est. completion date | September 2019 |
| Est. primary completion date | September 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Hong Kong | 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 | Tuen Mun Hospital | Hong Kong | |
| Hong Kong | United Christian Hospital | Hong Kong |
| Lead Sponsor | Collaborator |
|---|---|
| The University of Hong Kong | Pamela Youde Nethersole Eastern Hospital, Prince of Wales Hospital, Shatin, Hong Kong, Queen Mary Hospital, Hong Kong, Ruttonjee Hospital, Tuen Mun Hospital, United Christian Hospital |
Hong Kong,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to achieve adequate sedation | Adequate sedation is determined by a 6-point validated scale. | Within 60 minutes from drug administration | |
| Secondary | 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 | ||
| Secondary | Prolonged QTc interval | From Emergency Department admission to transfer or discharge from Emergency Department, an expected average of 1 hour | ||
| Secondary | AED length of stay (LOS) | From Emergency Department admission to transfer or discharge from Emergency Department, an expected average of 1 hour | ||
| Secondary | 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 | From Emergency Department admission to transfer or discharge from Emergency Department an expected average of 1 hour |