NCT02380118

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2014

Longer than P75 for phase_4

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

4.8 years

First QC Date

January 29, 2015

Last Update Submit

November 3, 2022

Conditions

Acute Agitation, Behavioural Emergency

Keywords

emergencyemergency medicinesedationacute agitation

Outcome Measures

Primary Outcomes (1)

  • Time to achieve adequate sedation

    Adequate sedation is determined by a 6-point validated scale.

    Within 60 minutes from drug administration

Secondary Outcomes (4)

  • 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

Study Arms (3)

Olanzapine

EXPERIMENTAL

intramuscular olanzapine injection (zyprexa), 5 mg/dose, first dose and an optional second dose.

Drug: Olanzapine

Haloperidol

ACTIVE COMPARATOR

intramuscular haloperidol injection, 5 mg/dose, first dose and an optional second dose.

Drug: Haloperidol

Midazolam

ACTIVE COMPARATOR

intramuscular midazolam injection, 5 mg/dose, first dose and an optional second dose.

Drug: Midazolam

Interventions

OlanzapineDRUG

Intramuscular injection

Also known as: ZYPREXA
Olanzapine
HaloperidolDRUG

Intramuscular injection

Haloperidol
MidazolamDRUG

Intramuscular injection

Midazolam

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Emergency Department patients, requiring parenteral drug sedation (as determined by an emergency clinician) will be enrolled.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Ruttonjee Hospital

Hong Kong, Hong Kong

Location

Tuen Mun Hospital

Hong Kong, Hong Kong

Location

United Christian Hospital

Hong Kong, Hong Kong

Location

Related Publications (7)

  • 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. doi: 10.1111/j.1742-6723.2005.00756.x.

    PMID: 16091097BACKGROUND

  • 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.

    PMID: 22981685BACKGROUND

  • 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. doi: 10.1016/j.annemergmed.2005.07.003. Epub 2005 Aug 18.

    PMID: 16387219BACKGROUND

  • 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.

    PMID: 21091874BACKGROUND

  • 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. No abstract available.

    PMID: 19527287BACKGROUND

  • 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.

    PMID: 23186399BACKGROUND

  • Chan EW, Lao KSJ, Lam L, Tsui SH, Lui CT, Wong CP, Graham CA, Cheng CH, Chung TS, Lam HF, Ting SM, Knott JC, Taylor DM, Kong DCM, Leung LP, Wong ICK. Intramuscular midazolam, olanzapine, or haloperidol for the management of acute agitation: A multi-centre, double-blind, randomised clinical trial. EClinicalMedicine. 2021 Feb 11;32:100751. doi: 10.1016/j.eclinm.2021.100751. eCollection 2021 Feb.

    PMID: 33681744DERIVED

MeSH Terms

Conditions

Emergencies

Interventions

OlanzapineHaloperidolMidazolam

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsButyrophenonesKetonesOrganic Chemicals

Study Officials

  • Esther WY Chan, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 29, 2015

First Posted

March 5, 2015

Study Start

December 1, 2014

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

November 4, 2022

Record last verified: 2022-11

Locations

HK(6)