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Trial registered on ANZCTR


Registration number
ACTRN12616001489482
Ethics application status
Approved
Date submitted
24/10/2016
Date registered
26/10/2016
Date last updated
6/10/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
An audit of a change in clinical practice for Queensland Ambulance Service from midazolam to droperidol for patients with prehospital acute behavioural disturbance.
Scientific title
An audit of a change in clinical practice for Queensland Ambulance Service from midazolam to droperidol for prehospital acute behavioural disturbance.
Secondary ID [1] 290376 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute behavioural disturbance 300683 0
Condition category
Condition code
Public Health 300531 300531 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Hours
Description of intervention(s) / exposure
Patients with acute behavioural disturbance (ABD) managed by the Queensland Ambulance Service (QAS) are currently administered midazolam for their drug management. The QAS are replacing midazolam for droperidol in the drug management of ABD. We want to study this change in practice by QAS of these 2 drugs on there effectiveness and safety for the management of ABD.

Date for implementation for the change over to droperidol is 15th November 2016. The audit period will run from this date until we have collected 130 patients who have received droperidol. It is expected that this will be reached by the 15th June 2017.

The source of the data for the study will be from a combination of the standard reporting form for QAS (eARF) and a purpose built audit form.

The regimen for droperidol is 10mg intramuscularly (IM) which can be repeated if the patient has not settled after 15 minutes to a total of 20mg. For patients >65 years the dose is 5mg IM which can be repeated if the patient has not settled after 15 minutes to a total dose of 10mg. The definition of settled is a reduction in the sedation assessment tool (SAT) score to 0 or lower or a reduction of 2 if the SAT score is 3.

The follow up period once the patient has settled is for 1 hour to assess the requirement for any re sedation.
Intervention code [1] 296202 0
Not applicable
Comparator / control treatment
The comparator group are patients with ABD who are receiving midazolam. The pre-implementation audit period with midazolam still in use will take place using a study audit form and standard ARF reporting from May 26th to November 14th 2016 will occur.
Control group
Active

Outcomes
Primary outcome [1] 299952 0
The primary outcome will be the proportion of patients with adverse events comparing those given midazolam and those given droperidol. Adverse events are defined as:

1. Airway obstruction requiring an airway maneuver i.e. chin lift/jaw thrust through to LMA/Intubation.
2. Oxygen saturations < 90% on room air and/or respiratory rate < 12/minute
3. Systolic blood pressure <90mmHg.
4. A SAT score of -3
5. Dystonic reactions
Timepoint [1] 299952 0
In the one hour after the drug has been given.
Secondary outcome [1] 328640 0
1. Time to sedation defined as the QAS arrival time at patient until the SAT score decreases by 2 points or more or there is a score of zero. This is reported on the study audit form and/or the eARF by QAS paramedics.
Timepoint [1] 328640 0
In the one hour after the drug has been given.
Secondary outcome [2] 328708 0
The requirement for additional sedation, defined as any medication administered for the purpose of sedation within 60 minutes of achieving sedation defined in secondary outcome 1 above. This is reported on the study audit form and/or the eARF by QAS paramedics.
Timepoint [2] 328708 0
In the one hour after the drug has been given.
Secondary outcome [3] 328709 0
The number of drug administrations used to sedate patients with midazolam and droperidol. This is reported on the study audit form and/or the eARF by QAS paramedics.
Timepoint [3] 328709 0
In the one hour after the drug has been given.
Secondary outcome [4] 328710 0
Number of injuries to patients and QAS staff. This is reported on the study audit form and/or the eARF by QAS paramedics.
Timepoint [4] 328710 0
In the one hour after the drug has been given.
Secondary outcome [5] 328711 0
Prehospital time defined as QAS arrival time at patient to time of arrival at destination (receiving hospital). This is reported on the study audit form and/or the eARF by QAS paramedics.
Timepoint [5] 328711 0
In the one hour after the drug has been given.

Eligibility
Key inclusion criteria
1. Patients presenting with ABD 16 years of age and greater with a sedation assessment tool (SAT) score of 2 and 3.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients presenting with ABD less than 16 years of age.
2. Patients with known adverse effects e.g. dystonic reaction or known allergy to droperidol or midazolam.
3. Patients with Parkinson’s disease.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data will be entered into an ExcelTM spreadsheet. The primary and secondary outcomes will be reported using descriptive statistics including medians, interquartile ranges and ranges for continuous data; and proportions with 95% confidence intervals for dichotomous outcomes. Appropriate statistical tests will be used for comparison between the two study groups.

For primary outcome - chi square or Fisher's exact test.

For secondary outcomes - chi square or Fisher's exact for proportional outcomes and student’s t-test or non-parametric equivalent depending on the distribution of the data for continuous outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/05/2016
Date of last participant enrolment
Anticipated
15/06/2017
Actual
24/05/2017
Date of last data collection
Anticipated
25/07/2017
Actual
24/05/2017
Sample size
Target
260
Accrual to date
Final
290
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 294778 0
Self funded/Unfunded
Name [1] 294778 0
Country [1] 294778 0
Primary sponsor type
Individual
Name
Colin Page
Address
Department of Emergency Medicine
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
Queensland 4102
Country
Australia
Secondary sponsor category [1] 293615 0
None
Name [1] 293615 0
Address [1] 293615 0
Country [1] 293615 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296174 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 296174 0
Ethics committee country [1] 296174 0
Australia
Date submitted for ethics approval [1] 296174 0
22/04/2016
Approval date [1] 296174 0
29/04/2016
Ethics approval number [1] 296174 0
HREC/16/QPAH/287

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1196 1196 0 0
/AnzctrAttachments/371701-Prehospital droperidol_Version 4 October 2016.pdf (Protocol)
Attachments [2] 1197 1197 0 0
/AnzctrAttachments/371701-PHD_Ethics approval_29042016.pdf (Ethics approval)

Contacts
Principal investigator
Name 69862 0
Dr Colin Page
Address 69862 0
Department of Emergency Medicine
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
Queensland 4102
Country 69862 0
Australia
Phone 69862 0
+61 7 3176 2111
Fax 69862 0
Email 69862 0
cpage@bigpond.net.au
Contact person for public queries
Name 69863 0
Colin Page
Address 69863 0
Department of Emergency Medicine
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
Queensland 4102
Country 69863 0
Australia
Phone 69863 0
+61 7 3176 2111
Fax 69863 0
Email 69863 0
cpage@bigpond.net.au
Contact person for scientific queries
Name 69864 0
Colin Page
Address 69864 0
Department of Emergency Medicine
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
Queensland 4102
Country 69864 0
Australia
Phone 69864 0
+61 7 3176 2111
Fax 69864 0
Email 69864 0
cpage@bigpond.net.au

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

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