ANZCTR - Registration

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12619001205123

Ethics application status

Approved

Date submitted

8/08/2019

Date registered

28/08/2019

Date last updated

17/11/2021

Date data sharing statement initially provided

28/08/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Droperidol vs Ondansetron in Nausea Treatment in the Emergency Department (DONuT)

Scientific title

Therapeutic Management of Nausea in the Emergency Department: A randomised comparison of Droperidol and Ondansetron

Secondary ID [1]

none

Universal Trial Number (UTN)

Trial acronym

DONuTED

Linked study record

Health condition

Health condition(s) or problem(s) studied:

nausea

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Emergency medicine

Other emergency care

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Droperidol 2.5mg intravenously. One dose only. Participants will be randomised into intervention or control group. Once the participant has been allocated to the intervention group, the treating physician will chart the intervention on the electronic medication chart and the intervention will be given by the treating nurse, which will be subsequently logged. Fidelity will be monitored by review of the electronic medication chart within the electronic medical record - which will document the time when the intervention was administered.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Ondansetron 8mg intravenously. One dose only.

Control group

Active

Outcomes

Primary outcome [1]

Proportion of participants with a change in nausea of 5 mm or greater on a visual analog scale.

Timepoint [1]

30 minutes post-treatment

Secondary outcome [1]

Comparison of mean change in nausea between groups on a Visual Analog Scale.

Timepoint [1]

30 minutes post-treatment

Secondary outcome [2]

Comparison of patient centered outcome between groups, as response to the question “The medicine I received had the desired effect for me”, Yes or No

Timepoint [2]

30 minutes post-treatment

Secondary outcome [3]

Description of adverse events for all groups. Absence or presence (mild/moderate/severe) of headache or dizziness will be specifically noted. Agitation or sedation will be rated on the Richmond Agitation-Sedation Scale. Any other adverse events will be noted as free text.

Timepoint [3]

From 30 minutes post-treatment to conclusion of ED episode of care.

Eligibility

Key inclusion criteria

Emergency Department patients aged 18 years or more, with nausea and/or vomiting as a primary or secondary complaint (any underlying cause).

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

* Known allergy to ondansetron or droperidol
* Use of an agent with known antiemetic properties in the previous 4 hours, either prior to ED arrival, or earlier in the current ED episode of care. Includes: ondansetron, droperidol, metoclopramide, promethazine, chlorpromazine, prochlorperazine and any steroid medication.
* Patients considered too unwell to consent or participate for any reason, including cardiovascular instability, hepatic failure, renal failure or altered mental state.
* Contraindication to the administration of normal saline infusion during the study period (e.g. left ventricular failure, chronic renal failure)
* Patients with Parkinson’s disease or restless leg syndrome.
* Patients taking a dopamine antagonist for any reason. Includes: amisulpride, chlorpromazine, clopenthixol or flupenthixol, domperidone, haloperidol, paliperidone, quetiapine, risperidone, thioridazine.
* Patients with cognitive impairment or language barrier which compromises understanding of the outcome measurements.
* Patients with motion related nausea or vertigo, which have other specific recommended treatments, albeit with little supporting evidence
* Pregnant or breast feeding women; ondansetron is category B and droperidol category C, with both being excreted to breast milk
* Chemotherapy or radiotherapy induced nausea and vomiting (CINV or RINV), which have other specific recommended antiemetic treatments
* Inability to comply with an instruction to not drive or operate machinery for a minimum of 4 hours post-dosage; droperidol may impair these functions for a period of time, although 1.25 mg IV is a relatively small dose compared with dosages used for other indications

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)

Computer generated random numbers to allocate sequentially numbered, sealed/opaque envelopes, to treatment group 1 (ondansetron) or treatment group 2 (droperidol)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created in Microsoft Excel

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

The measured difference on the visual analog scale between time of medication administration and 30 minutes later will be considered the nausea improvement score.

Power calculation (0.8) based on number of participants required to detect a 20% difference between the nausea improvement score for each of the two interventions. Although a previous study suggested no difference between the two medications, this was conducted using significantly lower dose of droperidol.

Comparison of the nausea improvement scores between both intervention groups will be done using the t-test.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/01/2020

Actual

4/02/2020

Date of last participant enrolment

Anticipated

1/10/2020

Actual

18/08/2021

Date of last data collection

Anticipated

1/10/2020

Actual

18/08/2021

Sample size

Target

120

Accrual to date

Final

180

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Port Macquarie Base Hospital - Port Macquarie

Recruitment hospital [2]

Kempsey District Hospital - Kempsey

Recruitment postcode(s) [1]

2444 - Port Macquarie

Recruitment postcode(s) [2]

2440 - Kempsey

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Port Macquarie Base Hospital

Address [1]

Wrights Road Port Macquarie 2444 NSW

Country [1]

Australia

Primary sponsor type

Individual

Name

A/Prof Gabriel T Lau

Address

Emergency Department
Port Macquarie Base Hospital
Wrights Road
Port Macquarie 2444 NSW

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Lachlan Philpott

Address [1]

UNSW Rural Clinical School Port Macquarie Campus 26 Highfields Circuit PORT MACQUARIE NSW 2444 AUSTRALIA

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

North Coast Human Research Ethics Committee

Ethics committee address [1]

PO Box 821 
Murwillumbah NSW 2484

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/08/2019

Approval date [1]

11/10/2019

Ethics approval number [1]

2019/ETH12203

Summary

Brief summary

Ondansetron is an anti-emetic drug that is commonly used in the emergency department to treat nausea and vomiting. Droperidol is an older anti-emetic medication where usage had fallen out of favour until recently, due to unfounded fears concerning QT prolongation. There is anecdotal evidence that IV droperidol is superior to ondansetron for treatment of nausea and vomiting.  Although no difference was noted between the two drugs in a recent study, the dose of droperidol that was used was less that what would commonly be used in an emergency department setting.  The question is if a higher dose of droperidol will likely demonstrate a difference.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Gabriel T Lau

Address

Emergency Department Port Macquarie Base Hospital Wrights Road Port Macquarie 2444 NSW

Country

Australia

Phone

+61 0466 140 339

Fax

[email protected]

Contact person for public queries

Name

Gabriel T Lau

Address

Emergency Department Port Macquarie Base Hospital Wrights Road Port Macquarie 2444 NSW

Country

Australia

Phone

+61 0466 140 339

Fax

[email protected]

Contact person for scientific queries

Name

Gabriel T Lau

Address

Emergency Department Port Macquarie Base Hospital Wrights Road Port Macquarie 2444 NSW

Country

Australia

Phone

+61 0466 140 339

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Case-by-case at discretion of the primary sponsor

Conditions for requesting access:
• -

What individual participant data might be shared?

• All de-identified data collected during this trial

What types of analyses could be done with individual participant data?

• Any purpose

When can requests for individual participant data be made (start and end dates)?

From:
Beginning 3 months and ending 5 years following main results publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Data will be provided by e-mail from principle investigator - contact [email protected]

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Email
3002	Study protocol	[email protected]
3003	Statistical analysis plan	[email protected]
3004	Informed consent form	[email protected]
3005	Clinical study report	[email protected]
3006	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

Source	Title	Year of Publication	DOI
Embase	Droperidol versus ondansetron for nausea treatment within the emergency department.	2023	https://dx.doi.org/10.1111/1742-6723.14174

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically