Trial Review

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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] 253156 0
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 260914 0
Condition category
Condition code
Other 259052 259052 0 0
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] 257660 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259712 0
The proportion of patients who have abnormal QT interval based on the QT nomogram following the administration of droperidol.
Timepoint [1] 259712 0
Within the first hour after the administration of droperidol 10 mg IMI and at 4 hours or discharge.
Secondary outcome [1] 266431 0
Time to sedation as determined by a reduction in the Sedation Assessment Tool (SAT) by 2 points or a score of zero.
Timepoint [1] 266431 0
15 minutes and 30 minutes and 60 minutes post administration of Droperidol 10 mg IMI
Secondary outcome [2] 268757 0
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] 268757 0
Within 2 hrs of administration of Droperidol 10 mg IMI
Secondary outcome [3] 268758 0
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] 268758 0
Within one hour of the initial administration of Droperidol 10 mg IMI
Secondary outcome [4] 268759 0
Requirement for Re-sedation defined as a repeat acute behavioural disturbance after being initially sedated.
Timepoint [4] 268759 0
After one hour has elapsed without the need for any sedation for up to 4 hours post droperidol
Secondary outcome [5] 268760 0
Injuries to the patient, staff or other patients or property
Timepoint [5] 268760 0
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?
No
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] 3471 0
4215
Recruitment postcode(s) [2] 3472 0
2305
Recruitment postcode(s) [3] 3473 0
2320
Recruitment postcode(s) [4] 3474 0
2330

Funding & Sponsors
Funding source category [1] 258128 0
Self funded/Unfunded
Name [1] 258128 0
N/A
Country [1] 258128 0
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] 257303 0
None
Name [1] 257303 0
N/A
Address [1] 257303 0
N/A
Country [1] 257303 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260109 0
Ethics committee address [1] 260109 0
Ethics committee country [1] 260109 0
Date submitted for ethics approval [1] 260109 0
30/11/2010
Approval date [1] 260109 0
Ethics approval number [1] 260109 0

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 31949 0
Address 31949 0
Country 31949 0
Phone 31949 0
Fax 31949 0
Email 31949 0
Contact person for public queries
Name 15196 0
Dr Geoffrey Isbister
Address 15196 0
Department of Clinical Toxicology/ Pharmacology
Level 5 New Med Building
Calvary Mater Newcastle
Edith Street
Waratah 2298
NSW
Country 15196 0
Australia
Phone 15196 0
+61 2 4921 1627
Fax 15196 0
+61 2 4921 1870
Email 15196 0
[email protected]
Contact person for scientific queries
Name 6124 0
Dr Geoffrey Isbister
Address 6124 0
Department of Clinical Toxicology/ Pharmacology
Level 5 New Med Building
Calvary Mater Newcastle
Edith Street
Waratah 2298
NSW
Country 6124 0
Australia
Phone 6124 0
+61 2 4921 1627
Fax 6124 0
+61 2 4921 1870
Email 6124 0
[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
SourceTitleYear of PublicationDOI
EmbaseThe Safety and Effectiveness of Droperidol for Sedation of Acute Behavioral Disturbance in the Emergency Department.2015https://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.