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Trial registered on ANZCTR


Registration number
ACTRN12611000565943
Ethics application status
Approved
Date submitted
12/05/2011
Date registered
2/06/2011
Date last updated
6/11/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial for the management of acute behavioural disturbance comparing haloperidol versus droperidol for the most effective sedation in psychiatric intensive care patients.
Scientific title
A randomised controlled trial for the management of acute behavioural disturbance comparing haloperidol versus droperidol for the most effective sedation in the psychiatric intensive care patient.
Secondary ID [1] 262297 0
Nil
Universal Trial Number (UTN)
Trial acronym
H.O.R.D.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute behavioural disturbance 265843 0
Condition category
Condition code
Mental Health 265997 265997 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised controlled trial comparing the administration of haloperidol 10mg (arm 1)or droperidol 10mg (arm 2 ) for acute behavioural disturbance. Intramuscular injection of same single initial dose only.
Intervention code [1] 264570 0
Treatment: Drugs
Comparator / control treatment
2 arms only. Nil placebo. Nil combination.
Arm 1:Haloperidol 10mg
Arm 2:Droperidol 10mg
Control group
Active

Outcomes
Primary outcome [1] 266737 0
1.Time from the administration of trial drug until sedation is achieved, determined by score on the Sedation Assessment Tool ( SAT) being reduced by two points or returned to zero (calm and alert).
Not a validated tool.
Timepoint [1] 266737 0
From the time of administration of the study drug until sedation is achieved.
Secondary outcome [1] 276279 0
1.The frequency of adverse drug effects:
a. Oxygen desaturation < 90%
b. Airway obstruction
c. Hypotension (systolic BP < 90 mmHg)
d. Extrapyramidal side-effects
a,b and c are normal vital signs monitoring and are recorded routinely on the observation chart and data sheets. Extrapyramidal side effects are an observation made by clinicians and/or recorded and treated due to patient discomfort.
Timepoint [1] 276279 0
From the time of administration of the study drug until 1 hour post dose for a.b.c and d.
Secondary outcome [2] 276280 0
2.Requirement for additional parenteral sedation as per the Sedation Assessment Tool ( SAT) score of +2 or +3 after 15 minutes after the initial administration.
Timepoint [2] 276280 0
From the time of administration of the study drug until 4 hours post dose
Secondary outcome [3] 276281 0
3.Incidence of injuries to the patients or staff members, as reported by members of staff.
Timepoint [3] 276281 0
From the time of administration of the study drug until 4 hours post dose

Eligibility
Key inclusion criteria
1.Psychiatric intensive care patients with acute behavioural disturbance at risk to themselves or others;
AND
2.Require being placed in seclusion or physical restraint to protect themselves and others
Minimum age
18 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Patients who are willing to take oral medication for sedation without physical restraint or seclusion;
2.Patients under the age of 18 years of age

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)
All psychiatric intensive care staff and associated mental health care workers will be made aware of the study with education sessions. When patients require sedation for acute behavioural disturbance recruitment will be based on inclusion and exclusion criteria and clinical judgement.The allocation of the 2 arms of the study are double blinded. The allocation is concealed by numbered identical containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All psychiatric intensive care staff and associated mental health care workers will be made aware of the study with education sessions. When patients require sedation for acute behavioural disturbance recruitment will be based on inclusion and exclusion criteria and clinical judgement. Randomised pre-packed study kits will be available. The randomisation process used for this a computerised sequence generation Each kit will have one vial randomised to contain either:
1.10mg droperidol in 2mL
2.10 mg haloperidol in 2mL
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 265056 0
Self funded/Unfunded
Name [1] 265056 0
Dr GK Isbister
Address [1] 265056 0
Calvary Mater Newcastle
Edith Street
Waratah 2298
NSW
Country [1] 265056 0
Australia
Primary sponsor type
Individual
Name
Dr G.K. Isbister
Address
Calvary Mater Newcastle
Department of clinical pharmacology and toxicology
Edith Street
Waratah 2298
NSW
Country
Australia
Secondary sponsor category [1] 264152 0
None
Name [1] 264152 0
Address [1] 264152 0
Country [1] 264152 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267044 0
Hunter New England
Ethics committee address [1] 267044 0
Lambton Road
New Lambton Heights 2305
NSW
Ethics committee country [1] 267044 0
Australia
Date submitted for ethics approval [1] 267044 0
20/05/2011
Approval date [1] 267044 0
14/06/2011
Ethics approval number [1] 267044 0
11/04/20/3.05

Summary
Brief summary
Aggressive behaviour related to acute psychosis is an ever present problem in emergency admissions to psychiatric wards and intensive care units. It can lead to patient harm and prolonged distress, injury to staff and/or other patients and damage to hospital property if the situation is not rapidly controlled. Intramuscular sedation is commonly used to manage these patients when all other attempts including verbal de-escalation and oral sedation have failed. The most commonly used drugs for this purpose have been benzodiazepines and antipsychotics given by the intramuscular route, mainly midazolam and haloperidol.
Intramuscular midazolam has proven to be unpredictable and can lead to both over-or under sedation of the acutely disturbed patient. It has a significant adverse effect profile due to over-sedation with respiratory depression and/or loss of airways patency. Conversely it is associated with under sedation when used to sedate patients with benzodiazepine tolerance. For this reason we no longer recommend the use of intramuscular midazolam for rapid sedation of acute behavioural disturbance in the emergency department. Haloperidol is also commonly used in this patient cohort but is associated with a high risk of extrapyramidal side effects and a risk of QT prolongation with associated Torsades de Pointes. Droperidol is less commonly used but is a highly sedative antipsychotic medication that is rarely associated with complications. This study aims to compare the effectiveness of droperidol compared to haloperidol for the sedation of aggressive patients with acute functional psychotic symptoms in a randomised controlled trial. The study is designed to assess both the speed of onset, effectiveness, and adverse effect profile of both agents.

AIMS:
This study aims to:
1. Compare the effectiveness of intramuscular droperidol to intramuscular haloperidol for sedation of aggressive patients with acute behavioural disturbance based on:
a. the time until sedation occurs;
b. the requirements for additional sedation.
2. Investigate the safety of intramuscular droperidol compared to haloperidol
3. Determine the practicality and effectiveness of introducing a sedation protocol into the psychiatric intensive care setting for patients with acute behavioural disturbance with related violent and aggressive symptoms;

HYPOTHESES:
The specific hypotheses of the study are that:
1. The time to sedation with intramuscular droperidol is shorter than intramuscular haloperidol;
2. Initial sedation with droperidol will require less additional sedation attempts compared to haloperidol;
3. Droperidol will result in a smaller proportion of extrapyramidal side-effects compared to haloperidol;
Trial website
Trial related presentations / publications
Not published as yet
Public notes

Contacts
Principal investigator
Name 32407 0
A/Prof Geoffrey K Isbister
Address 32407 0
Calvary Mater Newcastle
Edith Street Waratah
NSW 2298
Country 32407 0
Australia
Phone 32407 0
610249211312
Fax 32407 0
Email 32407 0
geoff.isbister@gmail.com
Contact person for public queries
Name 15654 0
A/Prof A.Prof. G.K. Isbister
Address 15654 0
Calvary Mater Newcastle
Edith Street
Waratah 2298
NSW
Country 15654 0
Australia
Phone 15654 0
+61 2 49 21 1627
Fax 15654 0
+61 2 49 21 1870
Email 15654 0
geoff.isbister@gmail.com
Contact person for scientific queries
Name 6582 0
A/Prof A.Prof. G.K. Isbister
Address 6582 0
Calvary Mater Newcastle
Edith Street
Waratah 2298
NSW
Country 6582 0
Australia
Phone 6582 0
+61 2 49 21 1627
Fax 6582 0
+61 2 49 21 1870
Email 6582 0
geoff.isbister@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary