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IM Olanzapine Versus Haloperidol or Midazolam

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ClinicalTrials.gov Identifier: NCT02380118
Recruitment Status : Recruiting
First Posted : March 5, 2015
Last Update Posted : April 18, 2019
Sponsor:
Collaborators:
Queen Mary Hospital, Hong Kong
Tuen Mun Hospital
Pamela Youde Nethersole Eastern Hospital
Ruttonjee Hospital
Prince of Wales Hospital, Shatin, Hong Kong
United Christian Hospital
Information provided by (Responsible Party):
Dr. Esther Wai Yin Chan, The University of Hong Kong

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Agitation, Behavioural Emergency Drug: Olanzapine Drug: Haloperidol Drug: Midazolam Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Intramuscular Olanzapine Versus Haloperidol or Midazolam for the Management of Acute Agitation in the Emergency Department - a Multicentre Randomised Clinical Trial
Actual Study Start Date : December 2014
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : March 2022


Arm Intervention/treatment
Experimental: Olanzapine
intramuscular olanzapine injection (zyprexa), 5 mg/dose, first dose and an optional second dose.
Drug: Olanzapine
Intramuscular injection
Other Name: 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




Primary Outcome Measures :
  1. Time to achieve adequate sedation [ Time Frame: Within 60 minutes from drug administration ]
    Adequate sedation is determined by a 6-point validated scale.


Secondary Outcome Measures :
  1. Total study drug doses administered; alternative drugs and doses used [ Time Frame: From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour ]
  2. QTc interval [ Time Frame: From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour ]
  3. AED length of stay (LOS) [ Time Frame: From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour ]
  4. Adverse events [ Time Frame: From Accident & Emergency Department(AED) admission to transfer or discharge from AED, 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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>75 years.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02380118


Contacts
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Contact: Esther WY Chan, PhD 852 6716 0700 ewchan@hku.hk
Contact: Shijian Lao, Bsc 852 2831 5118 kiml1@hku.hk

Locations
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Hong Kong
Pamela Youde Nethersole Eastern Hospital Recruiting
Hong Kong, Hong Kong
Contact: Antony CP Wong         
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Colin A. Graham         
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: Ling Pong Leung         
Ruttonjee Hospital Recruiting
Hong Kong, Hong Kong
Contact: Tong Shun Chung         
Tuen Mun Hospital Recruiting
Hong Kong, Hong Kong
Contact: Chun Tat Lui         
United Christian Hospital Recruiting
Hong Kong, Hong Kong
Contact: Hiu Fung Lam         
Sponsors and Collaborators
The University of Hong Kong
Queen Mary Hospital, Hong Kong
Tuen Mun Hospital
Pamela Youde Nethersole Eastern Hospital
Ruttonjee Hospital
Prince of Wales Hospital, Shatin, Hong Kong
United Christian Hospital
Investigators
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Principal Investigator: Esther WY Chan, PhD The University of Hong Kong

Publications:
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Responsible Party: Dr. Esther Wai Yin Chan, Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02380118     History of Changes
Other Study ID Numbers: PR/CT 0309/2014 (SC)
HKU 789813M ( Other Grant/Funding Number: Research Grant Council, Hong Kong )
First Posted: March 5, 2015    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Keywords provided by Dr. Esther Wai Yin Chan, The University of Hong Kong:
emergency
emergency medicine
sedation
acute agitation
Additional relevant MeSH terms:
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Psychomotor Agitation
Emergencies
Disease Attributes
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Midazolam
Haloperidol
Olanzapine
Haloperidol decanoate
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents