IM Olanzapine Versus Haloperidol or Midazolam

November 3, 2022 updated by: Dr. Esther Wai Yin Chan, The University of Hong Kong

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital
      • Hong Kong, Hong Kong
        • Tuen Mun Hospital
      • Hong Kong, Hong Kong
        • United Christian Hospital
      • Hong Kong, Hong Kong
        • Pamela Youde Nethersole Eastern Hospital
      • Hong Kong, Hong Kong
        • Ruttonjee Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Olanzapine
intramuscular olanzapine injection (zyprexa), 5 mg/dose, first dose and an optional second dose.
Drug: Olanzapine
Intramuscular injection
Other Names:
  • ZYPREXA
Active Comparator: Haloperidol
intramuscular haloperidol injection, 5 mg/dose, first dose and an optional second dose.
Drug: Haloperidol
Intramuscular injection
Active Comparator: Midazolam
intramuscular midazolam injection, 5 mg/dose, first dose and an optional second dose.
Drug: Midazolam
Intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to achieve adequate sedation
Time Frame: Within 60 minutes from drug administration
Adequate sedation is determined by a 6-point validated scale.
Within 60 minutes from drug administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total study drug doses administered; alternative drugs and doses used
Time Frame: From Emergency Department admission to transfer or discharge from AED, an expected average of 1 hour
From Emergency Department admission to transfer or discharge from AED, an expected average of 1 hour
Prolonged QTc interval
Time Frame: From Emergency Department admission to transfer or discharge from Emergency Department, an expected average of 1 hour
From Emergency Department admission to transfer or discharge from Emergency Department, an expected average of 1 hour
AED length of stay (LOS)
Time Frame: From Emergency Department admission to transfer or discharge from Emergency Department, an expected average of 1 hour
From Emergency Department admission to transfer or discharge from Emergency Department, an expected average of 1 hour
Adverse events
Time Frame: From Emergency Department admission to transfer or discharge from Emergency Department an expected average of 1 hour
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

Prince of Wales Hospital, Shatin, Hong Kong
Queen Mary Hospital, Hong Kong
Tuen Mun Hospital
Pamela Youde Nethersole Eastern Hospital
United Christian Hospital
Ruttonjee Hospital

Investigators

  • Principal Investigator: Esther WY Chan, PhD, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

January 29, 2015

First Submitted That Met QC Criteria

March 4, 2015

First Posted (Estimate)

March 5, 2015

Study Record Updates

Last Update Posted (Actual)

November 4, 2022

Last Update Submitted That Met QC Criteria

November 3, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR/CT 0309/2014 (SC)
  • HKU 789813M (Other Grant/Funding Number: Research Grant Council, Hong Kong)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Agitation, Behavioural Emergency

Clinical Trials on Olanzapine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe