IM Olanzapine Versus Haloperidol or Midazolam

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02380118
• Other study ID #: PR/CT 0309/2014 (SC)
• Secondary ID: HKU 789813M
• Status: Terminated
• Phase: Phase 4
• Start date: December 2014
• Est. completion date: September 2019

Study information

• Verified date: November 2022
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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.

Related Conditions & MeSH terms

• Acute Agitation, Behavioural Emergency
• Emergencies
• Psychomotor Agitation

Intervention

Drug:
• Olanzapine
Intramuscular injection
• Haloperidol
Intramuscular injection
• Midazolam
Intramuscular injection

Locations

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

Sponsors (7)

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

Country where clinical trial is conducted

Hong Kong, 

References & Publications (6)

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

Outcome

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