ANZCTR - Registration

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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]

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

Condition category

Condition code

Emergency medicine

Other emergency care

Oral and Gastrointestinal

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]

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]

Reduction in nausea severity

Timepoint [1]

Change from initial paramedic assessment to arrival at the emergency department

Secondary outcome [1]

Change in nausea

Timepoint [1]

Change from initial paramedic assessment to arrival at the emergency department

Secondary outcome [2]

Vomiting episodes

Timepoint [2]

Time between initial paramedic assessment and arrival at emergency department

Secondary outcome [3]

Adverse medication reactions

Timepoint [3]

Any time between drug administration and arrival to the emergency department

Secondary outcome [4]

Rescue medications provided in the emergency department

Timepoint [4]

Any time between arrival and discharge from the emergency department.

Secondary outcome [5]

hospital admission.

Timepoint [5]

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?

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]

Charities/Societies/Foundations

Name [1]

Emergency Medicine Foundation

Address [1]

Country [1]

Australia

Primary sponsor type

Government body

Name

Queensland Ambulance Service

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Metro North Health Human Research Ethics Committee A

Ethics committee address [1]

https://metronorth.health.qld.gov.au/research/ethics-and-governance/human-research-ethics-committee

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/10/2023

Approval date [1]

Ethics approval number [1]

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

A/Prof Jaimi Greenslade

Address

Royal Brisbane and Women's Hospital, Butterfield Street, Herston, QLD, 4029

Country

Australia

Phone

+61 422383278

Fax

[email protected]

Contact person for public queries

Name

Jaimi Greenslade

Address

Royal Brisbane and Women's Hospital, Butterfield Street, Herston, QLD, 4029

Country

Australia

Phone

+61 422383278

Fax

[email protected]

Contact person for scientific queries

Name

Jaimi Greenslade

Address

Royal Brisbane and Women's Hospital, Butterfield Street, Herston, QLD, 4029

Country

Australia

Phone

+61 422383278

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Email
21750	Study protocol	[email protected]
21751	Analytic code	[email protected]
21752	Informed consent form	[email protected]
21753	Clinical study report	[email protected]
21754	Ethical approval	[email protected]

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.

Trial Review

Documents added manually

Documents added automatically