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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

Tracking Information
First Submitted Date  ICMJE January 29, 2015
First Posted Date  ICMJE March 5, 2015
Last Update Posted Date April 18, 2019
Actual Study Start Date  ICMJE December 2014
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2015)
Time to achieve adequate sedation [ Time Frame: Within 60 minutes from drug administration ]
Adequate sedation is determined by a 6-point validated scale.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02380118 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2015)
  • 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 ]
  • QTc interval [ Time Frame: From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour ]
  • 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 ]
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IM Olanzapine Versus Haloperidol or Midazolam
Official Title  ICMJE Intramuscular Olanzapine Versus Haloperidol or Midazolam for the Management of Acute Agitation in the Emergency Department - a Multicentre Randomised Clinical Trial
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute Agitation, Behavioural Emergency
Intervention  ICMJE
  • Drug: Olanzapine
    Intramuscular injection
    Other Name: ZYPREXA
  • Drug: Haloperidol
    Intramuscular injection
  • Drug: Midazolam
    Intramuscular injection
Study Arms  ICMJE
  • Experimental: Olanzapine
    intramuscular olanzapine injection (zyprexa), 5 mg/dose, first dose and an optional second dose.
    Intervention: Drug: Olanzapine
  • Active Comparator: Haloperidol
    intramuscular haloperidol injection, 5 mg/dose, first dose and an optional second dose.
    Intervention: Drug: Haloperidol
  • Active Comparator: Midazolam
    intramuscular midazolam injection, 5 mg/dose, first dose and an optional second dose.
    Intervention: Drug: Midazolam
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 3, 2016)
282
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2015)
375
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Esther WY Chan, PhD 852 6716 0700 ewchan@hku.hk
Contact: Shijian Lao, Bsc 852 2831 5118 kiml1@hku.hk
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02380118
Other Study ID Numbers  ICMJE PR/CT 0309/2014 (SC)
HKU 789813M ( Other Grant/Funding Number: Research Grant Council, Hong Kong )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Esther Wai Yin Chan, The University of Hong Kong
Study Sponsor  ICMJE The University of Hong Kong
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Esther WY Chan, PhD The University of Hong Kong
PRS Account The University of Hong Kong
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP