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IM Olanzapine Versus Haloperidol or Midazolam

Information source: The University of Hong Kong
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Agitation, Behavioural Emergency

Intervention: Olanzapine (Drug); Haloperidol (Drug); Midazolam (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: The University of Hong Kong

Official(s) and/or principal investigator(s):
Esther WY Chan, PhD, Principal Investigator, Affiliation: The University of Hong Kong

Overall contact:
Esther WY Chan, PhD, Phone: 852 6716 0700, Email: ewchan@hku.hk

Summary

The purpose of this study is to determine whether IM 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.

Clinical Details

Official title: Intramuscular Olanzapine Versus Haloperidol or Midazolam for the Management of Acute Agitation in the Emergency Department - a Multicentre Randomised Clinical Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Time to achieve adequate sedation

Secondary outcome:

Total study drug doses administered; alternative drugs and doses used

QTc interval

AED length of stay (LOS)

Adverse events

Detailed description: To address significant knowledge gaps by several means: 1. Investigate IM use of sedating 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 IM olanzapine, in comparison with conventional medicines (haloperidol or midazolam) in a three-arm comparison for the sedation of acutely agitated patients in AEDs. Specifically, we aim to determine if administration of IM olanzapine (a)is more effective than sedation with IM haloperidol or IM 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 AED attendance and/or admission requiring parenteral sedation. These may include patient demographic and regular medications and adherence.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Accident & 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>65 years.

Locations and Contacts

Esther WY Chan, PhD, Phone: 852 6716 0700, Email: ewchan@hku.hk

Pamela Youde Nethersole Eastern Hospital, Hong Kong, Hong Kong; Recruiting
Antony CP Wong

Prince of Wales Hospital, Hong Kong, Hong Kong; Recruiting
Colin A. Graham

Queen Mary Hospital, Hong Kong, Hong Kong; Recruiting
Ling Pong Leung

Ruttonjee Hospital, Hong Kong, Hong Kong; Recruiting
Tong Shun Chung

Tuen Mun Hospital, Hong Kong, Hong Kong; Recruiting
Chun Tat Lui

Additional Information

Related publications:

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.

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, 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.

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, 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, 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.

Starting date: December 2014
Last updated: March 4, 2015

Page last updated: August 23, 2015

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