Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000303549p
Ethics application status
Submitted, not yet approved
Date submitted
26/02/2024
Date registered
22/03/2024
Date last updated
22/03/2024
Date data sharing statement initially provided
22/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Brisbane-based Anti-Emetic Randomised Controlled Trial in the Prehospital Setting
Scientific title
Brisbane-based Anti-Emetic Randomised Controlled Trial in the Prehospital Setting: A multi-arm double blind, placebo-controlled trial comparing droperidol, metoclopramide, and ondansetron in reducing nausea severity
Secondary ID [1] 311555 0
Nil known
Universal Trial Number (UTN)
U1111-1304-3684
Trial acronym
BARPHS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nausea and vomiting 332919 0
Condition category
Condition code
Emergency medicine 329632 329632 0 0
Other emergency care
Oral and Gastrointestinal 329885 329885 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomised into one of 4 groups, 3 intervention groups and one control. The three intervention groups are as follows:

Intervention 1: Ondansetron, one single intravenous dose immediately after randomisation; 8mg/4mL

Intervention 2: Droperidol, one single intravenous dose immediately after randomisation; 1.25mg/2mL

Intervention 3: Metoclopramide, one single intravenous dose immediately after randomisation, 10mg/2mL

Adherence to intervention will be assessed by examining the medical record to determine whether the medication was given
Intervention code [1] 328008 0
Treatment: Drugs
Comparator / control treatment
Study arm 4: Sodium chloride 0.9%, single intravenous dose, presented as either 2mL or 4mL to help maintain blinding
Control group
Placebo

Outcomes
Primary outcome [1] 337418 0
Reduction in nausea severity
Timepoint [1] 337418 0
Change from initial paramedic assessment to arrival at the emergency department
Secondary outcome [1] 431800 0
Change in nausea
Timepoint [1] 431800 0
Change from initial paramedic assessment to arrival at the emergency department
Secondary outcome [2] 431802 0
Vomiting episodes
Timepoint [2] 431802 0
Time between initial paramedic assessment and arrival at emergency department
Secondary outcome [3] 431804 0
Adverse medication reactions
Timepoint [3] 431804 0
Any time between drug administration and arrival to the emergency department
Secondary outcome [4] 431805 0
Rescue medications provided in the emergency department
Timepoint [4] 431805 0
Any time between arrival and discharge from the emergency department.
Secondary outcome [5] 431806 0
hospital admission.
Timepoint [5] 431806 0
Any time during the index presentation

Eligibility
Key inclusion criteria
Patients will be included in this study if they are:
1. Aged greater than or equal to 20 years and are being treated by the Queensland Ambulance Service with nausea and/or vomiting of sufficient severity to require an antiemetic.
2. The paramedic intends to provide intravenous antiemetic therapy.
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnancy or breastfeeding
2. Nausea and/or vomiting associated with (within 14 days of) chemotherapy or radiotherapy.
3. Intolerance or allergy to ondansetron, metoclopramide, or droperidol
4. Current treatment with dopamine antagonists
5. Parkinson’s disease or restless legs syndrome.
6. Cognitive or language issues that may impede the ability to comprehend and complete consent and endpoint assessments.
7. Lewy body dementia
8. QT interval prolongation
9. Previous antiemetic use within the past 8 hours

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)
Allocation concealment will occur through the use of tamper proof envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using R software
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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Participant flow will be reported as per CONSORT guidelines. Baseline demographics will be reported. The primary analyses will be conducted on an intention-to-treat basis. The primary endpoint will be compared across treatment groups using multilevel regression modelling. Within this model, the station will be treated as a random effect and treatment as a fixed effect. The difference between groups with 95% confidence intervals will be recorded. While the primary analyses will be unadjusted, adjusted analyses will also be conducted to increase the precision of the estimates. These analyses will adjust for clinically relevant variables, including the volume of IV fluid administered and the time the patient is with the Queensland Ambulance Service.
No adjustment will be made to the error rate to account for multiple comparisons because multi-arm studies where multiple treatments are compared to a placebo do not have an increased family-wise error rate. Such studies may be associated with lower error rate as the correlations between comparisons eliminates bias due to the experimental therapies being compared to different control populations.
.
For dichotomous secondary endpoints (adverse effects, rescue medications, hospital admission), we will calculate the difference in proportions (with a 95% confidence interval) of patients meeting the endpoint in each active treatment compared to placebo. For continuous secondary endpoints (change in VAS, number of vomiting episodes, length of stay), the mean or median difference will be reported with 95% confidence intervals. Errors will be estimated using an appropriate distribution for the data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
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)
QLD

Funding & Sponsors
Funding source category [1] 315853 0
Charities/Societies/Foundations
Name [1] 315853 0
Emergency Medicine Foundation
Country [1] 315853 0
Australia
Primary sponsor type
Government body
Name
Queensland Ambulance Service
Address
Country
Australia
Secondary sponsor category [1] 317987 0
None
Name [1] 317987 0
Address [1] 317987 0
Country [1] 317987 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314706 0
Metro North Health Human Research Ethics Committee A
Ethics committee address [1] 314706 0
https://metronorth.health.qld.gov.au/research/ethics-and-governance/human-research-ethics-committee
Ethics committee country [1] 314706 0
Australia
Date submitted for ethics approval [1] 314706 0
31/10/2023
Approval date [1] 314706 0
Ethics approval number [1] 314706 0

Summary
Brief summary
Nausea and vomiting are common reasons for people to call an ambulance. In Queensland, paramedics can provide a medication called ondansetron to reduce the severity of nausea and vomiting. Alternative medicines, such as metoclopramide and droperidol, are also used in the emergency department or by ambulance services in other states. This study aims to determine the effectiveness of medicines for nausea and vomiting in the prehospital environment. We will randomly assign patients who have nausea and/or vomiting to receive either ondansetron, metoclopramide, droperidol or a placebo as a prehospital treatment. We hypothesise that the proportion of patients experiencing symptom relief will be higher in the 3 medication compared to placebo groups
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132462 0
A/Prof Jaimi Greenslade
Address 132462 0
Royal Brisbane and Women's Hospital, Butterfield Street, Herston, QLD, 4029
Country 132462 0
Australia
Phone 132462 0
+61 422383278
Fax 132462 0
Email 132462 0
jhgreensladeconsulting@gmail.com
Contact person for public queries
Name 132463 0
Jaimi Greenslade
Address 132463 0
Royal Brisbane and Women's Hospital, Butterfield Street, Herston, QLD, 4029
Country 132463 0
Australia
Phone 132463 0
+61 422383278
Fax 132463 0
Email 132463 0
jhgreensladeconsulting@gmail.com
Contact person for scientific queries
Name 132464 0
Jaimi Greenslade
Address 132464 0
Royal Brisbane and Women's Hospital, Butterfield Street, Herston, QLD, 4029
Country 132464 0
Australia
Phone 132464 0
+61 422383278
Fax 132464 0
Email 132464 0
jhgreensladeconsulting@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21750Study protocol  jhgreensladeconsulting@gmail.com
21751Analytic code  jhgreensladeconsulting@gmail.com
21752Informed consent form  jhgreensladeconsulting@gmail.com
21753Clinical study report  jhgreensladeconsulting@gmail.com
21754Ethical approval  jhgreensladeconsulting@gmail.com



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.