Brisbane-based Anti-Emetic Randomised Controlled Trial in the Prehospital Setting

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12624000303549

Acronym

BARPHS

Enrollment

Registered

2024-03-22

Start date

2025-02-28

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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/4mL Intervention 3: Metoclopramide, one single intravenous dose immediately after randomisation, 10mg/4mL Adherence to intervention will be assessed by examining the

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Healthy volunteers

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.

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

Outcome results