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Trial registered on ANZCTR


Registration number
ACTRN12619001205123p
Ethics application status
Submitted, not yet approved
Date submitted
8/08/2019
Date registered
28/08/2019
Date last updated
28/08/2019
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] 298702 0
none
Universal Trial Number (UTN)
Trial acronym
DONuTED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
nausea 314148 0
Condition category
Condition code
Oral and Gastrointestinal 312042 312042 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Emergency medicine 312520 312520 0 0
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] 314966 0
Treatment: Drugs
Comparator / control treatment
Ondansetron 8mg intravenously. One dose only.
Control group
Active

Outcomes
Primary outcome [1] 320678 0
Proportion of participants with a change in nausea of 5 mm or greater on a visual analog scale.
Timepoint [1] 320678 0
30 minutes post-treatment
Secondary outcome [1] 372466 0
Comparison of mean change in nausea between groups on a Visual Analog Scale.
Timepoint [1] 372466 0
30 minutes post-treatment
Secondary outcome [2] 372467 0
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] 372467 0
30 minutes post-treatment
Secondary outcome [3] 372468 0
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] 372468 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14198 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [2] 14199 0
Kempsey District Hospital - Kempsey
Recruitment postcode(s) [1] 27183 0
2440 - Kempsey
Recruitment postcode(s) [2] 27182 0
2444 - Port Macquarie

Funding & Sponsors
Funding source category [1] 303255 0
Hospital
Name [1] 303255 0
Port Macquarie Base Hospital
Address [1] 303255 0
Wrights Road
Port Macquarie 2444 NSW
Country [1] 303255 0
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] 303262 0
Individual
Name [1] 303262 0
Lachlan Philpott
Address [1] 303262 0
UNSW Rural Clinical School
Port Macquarie Campus
26 Highfields Circuit
PORT MACQUARIE NSW 2444 AUSTRALIA

Country [1] 303262 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303795 0
North Coast Human Research Ethics Committee
Ethics committee address [1] 303795 0
PO Box 821
Murwillumbah NSW 2484
Ethics committee country [1] 303795 0
Australia
Date submitted for ethics approval [1] 303795 0
08/08/2019
Approval date [1] 303795 0
Ethics approval number [1] 303795 0

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 94834 0
A/Prof Gabriel T Lau
Address 94834 0
Emergency Department
Port Macquarie Base Hospital
Wrights Road
Port Macquarie 2444 NSW
Country 94834 0
Australia
Phone 94834 0
+61 0466 140 339
Fax 94834 0
Email 94834 0
gabriel.lau@unsw.edu.au
Contact person for public queries
Name 94835 0
A/Prof Gabriel T Lau
Address 94835 0
Emergency Department
Port Macquarie Base Hospital
Wrights Road
Port Macquarie 2444 NSW
Country 94835 0
Australia
Phone 94835 0
+61 0466 140 339
Fax 94835 0
Email 94835 0
gabriel.lau@unsw.edu.au
Contact person for scientific queries
Name 94836 0
A/Prof Gabriel T Lau
Address 94836 0
Emergency Department
Port Macquarie Base Hospital
Wrights Road
Port Macquarie 2444 NSW
Country 94836 0
Australia
Phone 94836 0
+61 0466 140 339
Fax 94836 0
Email 94836 0
gabriel.lau@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified data collected during this trial
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Case-by-case at discretion of the primary sponsor
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Data will be provided by e-mail from principle investigator - contact gabriel.lau@unsw.edu.au
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Clinical study report
Ethical approval
How or where can supporting documents be obtained?
Type [1] 3002 0
Study protocol
Citation [1] 3002 0
Link [1] 3002 0
Email [1] 3002 0
gabriel.lau@unsw.edu.au
Other [1] 3002 0
Attachment [1] 3002 0
Type [2] 3003 0
Statistical analysis plan
Citation [2] 3003 0
Link [2] 3003 0
Email [2] 3003 0
gabriel.lau@unsw.edu.au
Other [2] 3003 0
Attachment [2] 3003 0
Type [3] 3004 0
Informed consent form
Citation [3] 3004 0
Link [3] 3004 0
Email [3] 3004 0
gabriel.lau@unsw.edu.au
Other [3] 3004 0
Attachment [3] 3004 0
Type [4] 3005 0
Clinical study report
Citation [4] 3005 0
Link [4] 3005 0
Email [4] 3005 0
gabriel.lau@unsw.edu.au
Other [4] 3005 0
Attachment [4] 3005 0
Type [5] 3006 0
Ethical approval
Citation [5] 3006 0
Link [5] 3006 0
Email [5] 3006 0
gabriel.lau@unsw.edu.au
Other [5] 3006 0
Attachment [5] 3006 0
Summary results
No Results