ANZCTR - Registration

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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]

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

Condition category

Condition code

Mental Health

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]

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]

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]

From the time of administration of the study drug until sedation is achieved.

Secondary outcome [1]

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]

From the time of administration of the study drug until 1 hour post dose for a.b.c and d.

Secondary outcome [2]

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]

From the time of administration of the study drug until 4 hours post dose

Secondary outcome [3]

3.Incidence of injuries to the patients or staff members, as reported by members of staff.

Timepoint [3]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/07/2011

Actual

12/08/2011

Date of last participant enrolment

Anticipated

31/07/2013

Actual

31/07/2013

Date of last data collection

Anticipated

Actual

Sample size

Target

230

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Dr GK Isbister

Address [1]

Calvary Mater Newcastle
Edith Street
Waratah 2298
NSW

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England

Ethics committee address [1]

Lambton Road
New Lambton Heights 2305
NSW

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/05/2011

Approval date [1]

14/06/2011

Ethics approval number [1]

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

A/Prof Geoffrey K Isbister

Address

Calvary Mater Newcastle
Edith Street Waratah
NSW 2298

Country

Australia

Phone

610249211312

Fax

geoff.isbister@gmail.com

Contact person for public queries

Name

A.Prof. G.K. Isbister

Address

Calvary Mater Newcastle
Edith Street
Waratah 2298
NSW

Country

Australia

Phone

+61 2 49 21 1627

Fax

+61 2 49 21 1870

geoff.isbister@gmail.com

Contact person for scientific queries

Name

A.Prof. G.K. Isbister

Address

Calvary Mater Newcastle
Edith Street
Waratah 2298
NSW

Country

Australia

Phone

+61 2 49 21 1627

Fax

+61 2 49 21 1870

geoff.isbister@gmail.com

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

Source	Title	Year of Publication	DOI
Embase	Droperidol v. haloperidol for sedation of aggressive behaviour in acute mental health: Randomized controlled trial.	2015	https://dx.doi.org/10.1192/bjp.bp.114.150227

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically