ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12611000031965

Ethics application status

Not yet submitted

Date submitted

5/01/2011

Date registered

10/01/2011

Date last updated

10/01/2011

Type of registration

Prospectively registered

Titles & IDs

Public title

Droperidol for rapid sedation of acute behavioural disturbance

Scientific title

Cardiac safety study of droperidol for rapid sedation of acute behavioural disturbance in the emergency department

Secondary ID [1]

nil

Universal Trial Number (UTN)

Trial acronym

DORM II Observational study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Acute behaviour disturbance

Condition category

Condition code

Other

Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Droperidol 10 mg given by intramuscular injection administered for rapid sedation will be followed by a strict regime of monitoring of vital signs and an ECG recording The ECG will be obtained as soon as possible directly after the sedative has been given and at 4 hours or discharge Sedation scoring will be recorded throughout on a regime of 5 minutely for 20 minutes, again at 10 minutes, then half hourly until the patient wakes up or is calm. Any adverse drug effects will be noted and recorded.

Intervention code [1]

Not applicable

Comparator / control treatment

Not applicable

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The proportion of patients who have abnormal QT interval based on the QT nomogram following the administration of droperidol.

Timepoint [1]

Within the first hour after the administration of droperidol 10 mg IMI and at 4 hours or discharge.

Secondary outcome [1]

Time to sedation as determined by a reduction in the Sedation Assessment Tool (SAT) by 2 points or a score of zero.

Timepoint [1]

15 minutes and 30 minutes and 60 minutes post administration of Droperidol 10 mg IMI

Secondary outcome [2]

The proportion of patients who have an adverse effect. These include respiratory depression requiring intubation, TdP and other cardiac arrhythmias, severe extra pyramidal side effects, Severe hypotension or other other major unexpcted side effects.

Timepoint [2]

Within 2 hrs of administration of Droperidol 10 mg IMI

Secondary outcome [3]

Requirement of additional sedation defined as if the patient remains agitated as scored on the SAT at +2 or +3 after 15 minutes and receives further medication.

Timepoint [3]

Within one hour of the initial administration of Droperidol 10 mg IMI

Secondary outcome [4]

Requirement for Re-sedation defined as a repeat acute behavioural disturbance after being initially sedated.

Timepoint [4]

After one hour has elapsed without the need for any sedation for up to 4 hours post droperidol

Secondary outcome [5]

Injuries to the patient, staff or other patients or property

Timepoint [5]

Any time point within the study period of 4 hours post droperidol 10mg

Eligibility

Key inclusion criteria

Acute behaviour disturbance and is scoring +2 to +3 on the sedation assessment tool, defined as aggresive/violent loud outbusts and combative.
The patient is at risk to themselves or others and requires physical restraint for safety.

Minimum age

18 Years

Maximum age

99 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Under the age of 18 years.
Is able to be talked down.
Has agreed to the offer of oral medication with good result.

Study design

Purpose

Duration

Cross-sectional

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/04/2011

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

1000

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

4215

Recruitment postcode(s) [2]

2305

Recruitment postcode(s) [3]

2320

Recruitment postcode(s) [4]

2330

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

N/A

Address [1]

N/A

Country [1]

Primary sponsor type

Individual

Name

A/Prof. G.K.Isbister

Address

Dr G.K.Isbister
Department of pharmocology and Toxicology
Level 5 New Med building
Calvary Mater Newcastle
Edith Street
Waratah 2298
NSW

Country

Australia

Secondary sponsor category [1]

None

Name [1]

N/A

Address [1]

N/A

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

30/11/2010

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

The recent randomised controlled trial of Droperidol versus Midazolam for acute behaviour disturbance (ACTRN 12607000527460) resulted in the drug type being droperidol as effective at sedation as Midazolam but with significantly less adverse effects. There was no significant QT abnormalities. With ethics approval an extension to this trial followed and we have introduced  a protocol of sedation with inclusion criteria and guidelines with the recommendation to give droperidol in a set dose and route as an observational study  in the emergency department. This extension of the original trial has resulted in positive outcome for both patients and staff. The patient cohort is over 250 patients to date with no serious adverse effects. We now wish to extend this observational study to include rural regional and metropolitan hospitals to increase the sample size of the safety study.

Trial website

www.star.ferntree.com

Trial related presentations / publications

Isbister GK, Calver LA, Page CB, Stokes B, Bryant JL, Downes MA. Randomised comparison study of intramuscular droperidol versus midazolam for violence and acute behavioural disturbance – the DORM study. Ann Emerg Med. 2010 Oct;56(4):392-401

Calver LA, Downes MA, Page CB, Bryant JL, Isbister GK. The impact of a standardised intramuscular sedation protocol for acute behavioural disturbance in the emergency department. BMC Emerg Med. 2010 Jun 28;10:14

Chan A, Isbister GK, Kirkpatrick CMJ, Duffull SB. Drug-induced QT prolongation and Torsades de Pointes: evaluation of a QT nomogram. QJM. 2007 Oct;100(10):609-15.

Isbister GK, Calver L, van Gorp F, Stokes B, Page CB. Inter-rater reliability of manual QT measurement and prediction of abnormal QT,HR pairs. Clin Toxicol (Phila). 2009 Nov;47(9):884-8

Downes M, Healy P, Page CB, Bryant JL, Isbister GK. Code Black: A Structured Approach to the Agitated Patient in the Emergency Department. Emerg Med Australas. 2009 Jun;21(3):196-202

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Geoffrey Isbister

Address

Department of Clinical Toxicology/ Pharmacology
Level 5 New Med Building
Calvary Mater Newcastle
Edith Street
Waratah 2298
NSW

Country

Australia

Phone

+61 2 4921 1627

Fax

+61 2 4921 1870

[email protected]

Contact person for scientific queries

Name

Dr Geoffrey Isbister

Address

Department of Clinical Toxicology/ Pharmacology
Level 5 New Med Building
Calvary Mater Newcastle
Edith Street
Waratah 2298
NSW

Country

Australia

Phone

+61 2 4921 1627

Fax

+61 2 4921 1870

[email protected]

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	The Safety and Effectiveness of Droperidol for Sedation of Acute Behavioral Disturbance in the Emergency Department.	2015	https://dx.doi.org/10.1016/j.annemergmed.2015.03.016

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

Trial Review

Documents added manually

Documents added automatically