Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000527460
Ethics application status
Approved
Date submitted
4/10/2007
Date registered
12/10/2007
Date last updated
12/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Droperidol OR Midazolam (DORM) for sedation in patients with psychostimulant induced agitation
Scientific title
A randomised controlled trial of intramuscular droperidol versus intramuscular midazolam for rapid sedation of aggressive and agitated psychostimulant-associated delirium
Universal Trial Number (UTN)
Trial acronym
DORM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychostimulant induced agitation and delirium 2429 0
Condition category
Condition code
Injuries and Accidents 2531 2531 0 0
Poisoning

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intramuscular droperidol, single 10mg dose
Intervention code [1] 2149 0
Treatment: Drugs
Comparator / control treatment
1) Intramuscular midazolam, single 10mg dose and 2) intramuscular droperidol, single 5mg dose with intramuscular midazolam, single 5mg dose
Control group
Active

Outcomes
Primary outcome [1] 3430 0
Time until "all clear" by the security staff [ie. patient is safely restrained and sedated] to estimate onset of sedation
Timepoint [1] 3430 0
Outcome is a measure of time which commences at the time of intramuscular administration of treatment or comparator drugs
Primary outcome [2] 3431 0
Time until the next dose of parenteral medication for sedation to estimate duration of sedation
Timepoint [2] 3431 0
Outcome is a measure of time
Secondary outcome [1] 5698 0
Reduction in a 6-point agitation scale (6=highly aroused and violent, 0=asleep)
Timepoint [1] 5698 0
From baseline to 20 minutes after trial medication
Secondary outcome [2] 5699 0
Reduction in the altered mental status scale
Timepoint [2] 5699 0
From baseline to 20 minutes after trial medication
Secondary outcome [3] 5700 0
Injuries to the patient or staff members
Timepoint [3] 5700 0
During Emergency Department [ED] admission
Secondary outcome [4] 5701 0
Requirement for further parenteral sedation
Timepoint [4] 5701 0
During Emergency Department [ED] admission
Secondary outcome [5] 5702 0
Total oral sedation required
Timepoint [5] 5702 0
During Emergency Department [ED]admission
Secondary outcome [6] 5703 0
Further calls for security staff to the patient
Timepoint [6] 5703 0
During Emergency Department [ED] admission

Eligibility
Key inclusion criteria
Emergency department patients with suspected or confirmed severe agitated delirium/psychosis or aggression due to psychostimulant toxicity; AND require intervention by hospital security staff or physical restraint
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with acute psychosis clearly due to other causes;
2. Patient who are willing to take oral or intravenous medication for sedation without physical restraint;
3. 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 patients presenting to the ED meeting the inclusion criteria will be enrolled. Patient consent will be waived due to the treatment being administered based on a Duty of Care. Enrolled patients will then be blindly allocated to one of three treatment arms. Identical treatment kits (containers) containing the 3 different treatments will be numbered sequentially which will only be used by the treating doctors once the patient has been recruited. There is no way that the treating doctor or research assistant will be aware of the allocation because all of the treatment kits will be identical and number for sequential use, so they will not know what is in the treatment kit even if they look at it.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatment kits will be randomised in blocks and numbered sequentially.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
There will be three parallel arms:
1. 10mg droperidol (2 x 5mg droperidol in 2mL)
2. 10mg midazolam (2 x 5mg midazolam in 2mL)
3. 5mg droperidol + 5mg midazolam (5mg droperidol in 2mL + 5mg midazolam in 2mL)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2008
Actual
27/08/2008
Date of last participant enrolment
Anticipated
Actual
25/07/2009
Date of last data collection
Anticipated
Actual
26/07/2009
Sample size
Target
120
Accrual to date
Final
91
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 451 0
2298

Funding & Sponsors
Funding source category [1] 2680 0
Hospital
Name [1] 2680 0
NSW Health Drug and Alcohol
Country [1] 2680 0
Australia
Primary sponsor type
Individual
Name
Geoffrey Isbister
Address
Department of Clinical Toxicology and Pharmacology
Calvary Mater Hospital, Newcastle
Edith St Waratah NSW 2298
Country
Australia
Secondary sponsor category [1] 2421 0
None
Name [1] 2421 0
Address [1] 2421 0
Country [1] 2421 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4599 0
Hunter New England Area Human Research Ethics Committee
Ethics committee address [1] 4599 0
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 4599 0
Date submitted for ethics approval [1] 4599 0
28/09/2007
Approval date [1] 4599 0
Ethics approval number [1] 4599 0
Ethics committee name [2] 295729 0
Hunter and New England HREC
Ethics committee address [2] 295729 0
Newcastle
Ethics committee country [2] 295729 0
Australia
Date submitted for ethics approval [2] 295729 0
30/06/2007
Approval date [2] 295729 0
02/11/2007
Ethics approval number [2] 295729 0
7/10/24/3.05

Summary
Brief summary
Aggressive behaviour related to psychostimulant abuse, poisoning and/or withdrawal, such as amphetamines, is an increasing problem in emergency departments. It can lead to patient harm, injury to staff and damage to hospital property if the situation is not rapidly controlled. Intravenous sedation can be difficult, particularly in smaller urban and regional hospitals because it requires sufficient staff numbers to restrain the patient to obtain intravenous access and can lead to needle-stick injuries. Intramuscular sedation with benzodiazepines, mainly midazolam, is unpredictable and can lead to over-sedating the patient or not sedating them enough, and may be associated with problems in this group due to benzodiazepine tolerance. Droperidol is a highly sedative antipsychotic medication that is rarely associated with complications. This study aims to compare the effectiveness of intramuscular droperidol and intramuscular benzodiazepines for sedation of aggressive patients with psychostimulant associated agitation in a randomised controlled trial. The study is designed to assess both the speed of onset and duration of sedation.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 28092 0
Prof Geoffrey Isbister
Address 28092 0
Calvary Mater Newcastle
Waratah NSW 2298
Country 28092 0
Australia
Phone 28092 0
0438466471
Fax 28092 0
Email 28092 0
[email protected]
Contact person for public queries
Name 11249 0
Prof Geoff Isbister
Address 11249 0
Department of Clinical Toxicology and Pharmacology
Calvary Mater Hospital, Newcastle
Edith St Waratah NSW 2298
Country 11249 0
Australia
Phone 11249 0
612 49211211
Fax 11249 0
612 94754893
Email 11249 0
[email protected]
Contact person for scientific queries
Name 2177 0
Prof Geoff Isbister
Address 2177 0
Department of Clinical Toxicology and Pharmacology
Calvary Mater Hospital, Newcastle
Edith St Waratah NSW 2298
Country 2177 0
Australia
Phone 2177 0
612 49211211
Fax 2177 0
612 94754893
Email 2177 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
EmbasePopulation pharmacokinetics of intramuscular droperidol in acutely agitated patients.2016https://dx.doi.org/10.1111/bcp.13093
N.B. These documents automatically identified may not have been verified by the study sponsor.