Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000591459
Ethics application status
Approved
Date submitted
14/11/2007
Date registered
16/11/2007
Date last updated
10/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of droperidol and olanzepine in addition to midazolam for sedating very agitated patients: a multi-centre, randomised, controlled clinical trial
Scientific title
A randomised clinical trial to compare the efficacy of intravenous droperidol and olanzepine as adjuncts to midazolam for sedation of the severely agitated patient
Secondary ID [1] 288127 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
severe agitation 2549 0
Condition category
Condition code
Mental Health 2649 2649 0 0
Other mental health disorders
Other 2650 2650 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single intravenous bolus dose of 5mg droperidol (0.5mg/ml) or 5mg olanzapine (0.5mg/ml) immediately prior to sedation with intravenous midazolam
Intervention code [1] 2281 0
Treatment: Drugs
Comparator / control treatment
Single intravenous bolus of 10ml of normal saline (control)
Control group
Placebo

Outcomes
Primary outcome [1] 3560 0
Time to sedation as defined by a sedation score of less than or equal to 2 on a 6 point scale (6=highly agitated & violent, 0=asleep)
Timepoint [1] 3560 0
Adequate sedation will be expected within 60 minutes of commencement of initial drug administration
Secondary outcome [1] 5959 0
Need for re-sedation less than 60 minutes after sedation initially achieved
Timepoint [1] 5959 0
within 60 minutes of achieving adequate sedation initially

Eligibility
Key inclusion criteria
Emergecncy department patients who require chemical sedation as determined by an Emergency Physician or a senior registrar.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
known hypersensitivity to midazolam, droperidol or olanzepine, reversible aetiology for agitation (hypotension, hypoxia, hypoglycaemia), known pregnancy, acute alcohol withdrawal.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients requiring sedation will be determined by Emergency Physicians or Registrars. The next sequential study pack will be assigned to the patient. The study pack will contain the drugs randomly assigned to the patient. All drugs will be blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
copomputer generated random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
All people involved will be blinded. A double bummy approach will be employed.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2008
Actual
12/08/2009
Date of last participant enrolment
Anticipated
31/12/2010
Actual
27/03/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
320
Accrual to date
Final
336
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 321 0
3084, 3050, 3065

Funding & Sponsors
Funding source category [1] 2794 0
Charities/Societies/Foundations
Name [1] 2794 0
Australasian College for Emergency Medicine Research Foundation
Country [1] 2794 0
Australia
Primary sponsor type
Hospital
Name
Austin Hospital
Address
Studley Rd, Heidelber, VIc 3084
Country
Australia
Secondary sponsor category [1] 2525 0
Hospital
Name [1] 2525 0
Austin Health
Address [1] 2525 0
Studley Rd
Heidelberg, Vic 3084
Country [1] 2525 0
Australia
Other collaborator category [1] 88 0
Hospital
Name [1] 88 0
Royal Melbourne Hospital
Address [1] 88 0
Grattan Street, Parkville Vic 3050
Country [1] 88 0
Australia
Other collaborator category [2] 89 0
Hospital
Name [2] 89 0
St Vincents Hospital
Address [2] 89 0
Nicholson Street
Fitzroy, Vic 3065
Country [2] 89 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4713 0
Ethics committee address [1] 4713 0
Ethics committee country [1] 4713 0
Date submitted for ethics approval [1] 4713 0
14/11/2007
Approval date [1] 4713 0
21/08/2008
Ethics approval number [1] 4713 0

Summary
Brief summary
We believe that the addition of either 5mh of droperidol or 5mg olanzapine immediately prior to sedation with midazolam will result in safe and more effective sedation
Trial website
Trial related presentations / publications
Chan EW, Taylor DMcD, Knott JC, Phillips GA, Castle DJ, Kong DCM. Intravenous droperidol or olanzapine as adjuncts to midazolam for the acutely agitated patient: A multi-centre, randomised, double-blind, placebo-controlled clinical trial - Reply.
Annals Emerg Med 2013; 61: 598-599
Public notes

Contacts
Principal investigator
Name 28184 0
Prof David Taylor
Address 28184 0
Emergency Department
Austin Hospital
Studley Road
Heidelberg
Victoria
Australia 3084
Country 28184 0
Australia
Phone 28184 0
+61 3 9496 4711
Fax 28184 0
Email 28184 0
David.Taylor@austin.org.au
Contact person for public queries
Name 11341 0
Prof Prof David Taylor
Address 11341 0
Emergency Department
Austin Hospital
Studley Road
Heidelberg, Vic 3084
Country 11341 0
Australia
Phone 11341 0
03 9496 4883
Fax 11341 0
03 9496 3380
Email 11341 0
David.Taylor@austin.org.au
Contact person for scientific queries
Name 2269 0
Prof Prof David Taylor
Address 2269 0
Emergency Department
Austin Hospital
Studley Road
Heidelberg, Vic 3084
Country 2269 0
Australia
Phone 2269 0
03 9496 4883
Fax 2269 0
03 9496 3380
Email 2269 0
David.Taylor@austin.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIIntravenous midazolam–droperidol combination, droperidol or olanzapine monotherapy for methamphetamine-related acute agitation: subgroup analysis of a randomized controlled trial2017https://doi.org/10.1111/add.13780
Dimensions AIMidazolam-Droperidol, Droperidol, or Olanzapine for Acute Agitation: A Randomized Clinical Trial2016https://doi.org/10.1016/j.annemergmed.2016.07.033
N.B. These documents automatically identified may not have been verified by the study sponsor.