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Acute Agitation, Behavioural EmergencyPhase 4NCT02380118

IM Olanzapine Versus Haloperidol or Midazolam

A Phase 4 study testing Olanzapine, Haloperidol and Midazolam in people with Acute Agitation, Behavioural Emergency, run by The University of Hong Kong at 6 sites in Hong Kong.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Agitation, Behavioural Emergency
What is being tested?
Olanzapine, Haloperidol and Midazolam
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
167 participants
Where
6 sitesHong Kong
Study dates
Dec 2014to Sep 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Hong Kong6 sites

  • Pamela Youde Nethersole Eastern Hospital

    Hong Kong

  • Prince of Wales Hospital

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

  • Ruttonjee Hospital

    Hong Kong

  • Tuen Mun Hospital

    Hong Kong

  • United Christian Hospital

    Hong Kong

Other trials in Hong Kong

About this study

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

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.

Read the detailed 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.
Being tested
Olanzapine, Haloperidol, Midazolam
Keywords
emergency, emergency medicine, sedation, acute agitation
Medical subject headings
Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OlanzapineDrug

    Also called ZYPREXA

    Intramuscular injection

  • HaloperidolDrug

    Intramuscular injection

  • MidazolamDrug

    Intramuscular injection

Study groups in NCT02380118
Study groupRoleWhat they receive
OlanzapineExperimentalintramuscular olanzapine injection (zyprexa), 5 mg/dose, first dose and an optional second dose.
Receives: Drug: Olanzapine
HaloperidolActive comparatorintramuscular haloperidol injection, 5 mg/dose, first dose and an optional second dose.
Receives: Drug: Haloperidol
MidazolamActive comparatorintramuscular midazolam injection, 5 mg/dose, first dose and an optional second dose.
Receives: Drug: Midazolam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to achieve adequate sedation

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

    Measured: Within 60 minutes from drug administration

Secondary outcomes (4)

  1. Total study drug doses administered; alternative drugs and doses used

    Measured: From Emergency Department admission to transfer or discharge from AED, an expected average of 1 hour

  2. Prolonged QTc interval

    Measured: From Emergency Department admission to transfer or discharge from Emergency Department, an expected average of 1 hour

  3. AED length of stay (LOS)

    Measured: From Emergency Department admission to transfer or discharge from Emergency Department, an expected average of 1 hour

  4. 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

    Measured: From Emergency Department admission to transfer or discharge from Emergency Department an expected average of 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2015 (estimated)
  2. Study startDec 2014
  3. Primary completionSep 2019
  4. Study completionSep 2019

Why it stopped: Primary endpoint reached based on data projection from interim analysis.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02380118
Sponsor's protocol ID
PR/CT 0309/2014 (SC)
Other IDs
HKU 789813M
Status last verified
Nov 2022
First submitted
29 Jan 2015
Last updated
4 Nov 2022
Results posted
No
Data monitoring committee
Yes

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

    PubMed 16091097

  • 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.

    PubMed 22981685

  • 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.

    PubMed 16387219

  • 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.

    PubMed 21091874

  • 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.

    PubMed 19527287

  • 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.

    PubMed 23186399

  • 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.

    PubMed 33681744

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Olanzapine, Haloperidol and Midazolam in people with Acute Agitation, Behavioural Emergency, run by The University of Hong Kong at 6 sites in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Primary endpoint reached based on data projection from interim analysis.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to achieve adequate sedation (time frame: Within 60 minutes from drug administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02380118, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.

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