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Trial registered on ANZCTR


Registration number
ACTRN12617000224325
Ethics application status
Approved
Date submitted
8/02/2017
Date registered
10/02/2017
Date last updated
10/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Droperidol, Ondansetron, Placebo Antiemetic Trial for adult Emergency Department patients with nausea. (DOPAT)
Scientific title
Droperidol and Ondansetron compared with Placebo: a randomized controlled Antiemetic Trial of adult patients with nausea in the Emergency Department. (DOPAT)
Secondary ID [1] 291120 0
Nil known
Universal Trial Number (UTN)
U1111-1192-6351
Trial acronym
DOPAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nausea and vomiting 301951 0
Condition category
Condition code
Oral and Gastrointestinal 301602 301602 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
Arm D: Droperidol 1.25 mg intravenously, one dose only
Arm O: Ondansetron 8 mg intravenously, one dose only
Intervention code [1] 297105 0
Treatment: Drugs
Comparator / control treatment
Arm P: 0.9% normal saline placebo
Control group
Placebo

Outcomes
Primary outcome [1] 301003 0
Proportion of participants with a reduction in nausea of 5 mm or greater on a visual analog scale.
Timepoint [1] 301003 0
30 minutes post-treatment
Secondary outcome [1] 331400 0
Comparison of mean change in nausea between groups on a Visual Analog Scale.
Timepoint [1] 331400 0
30 minutes post-treatment
Secondary outcome [2] 331401 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] 331401 0
30 minutes post-treatment.
Secondary outcome [3] 331402 0
Comparison between groups of use of additional antiemetic medication, with drug and dose to be recorded on the study case report form..
Timepoint [3] 331402 0
30 minutes post-treatment
Secondary outcome [4] 331403 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 [4] 331403 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)
Central randomization by Pharmacy Department, Clinical Trials. This group is independent to all clinical units, will perform the randomization and will provide the syringes of de-identified study drugs..
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization.
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
Prior study support that ondansetron leads to symptom improvement (as defined for this study) in 83% of patients, compared with 63% for plabebo. A similar figure for droperidol was not known, but previous research suggests droperidol is at least as effective as ondansetron.. Based on replication of this, a sample of 112 per group was required to demonstrate difference between ondansetron and/or droperidol versus placebo. Aim to recruit 126 per group. Comparisons will primary utilize the chi square (or Fisher's Exact) test, and a Number Needed to Treat will be calculated. There was insufficient information to consider powering the study to compare ondansetron with droperidol.

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)
VIC
Recruitment hospital [1] 7444 0
Dandenong Hospital - Dandenong
Recruitment hospital [2] 7445 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [3] 7446 0
Casey Hospital - Berwick
Recruitment postcode(s) [1] 15264 0
3175 - Dandenong
Recruitment postcode(s) [2] 15265 0
3168 - Clayton
Recruitment postcode(s) [3] 15266 0
3806 - Berwick

Funding & Sponsors
Funding source category [1] 295560 0
Hospital
Name [1] 295560 0
Monash Emergency Research Fund
Address [1] 295560 0
c/- Emergency Department
Dandenong Hospital
David Street
Dandenong, Vic, 3175.
Country [1] 295560 0
Australia
Funding source category [2] 295562 0
Charities/Societies/Foundations
Name [2] 295562 0
Morson Taylor Foundation
Address [2] 295562 0
c/- Australasian College for Emergency Medicine
34 Jeffcott Street
West Melbourne, Vic, 3003
Country [2] 295562 0
Australia
Primary sponsor type
Individual
Name
Robert Meek
Address
c/- Emergency Department
Dandenong Hospital
David Street
Dandenong, Vic, 3175
Country
Australia
Secondary sponsor category [1] 294380 0
Individual
Name [1] 294380 0
Andis Graudins
Address [1] 294380 0
c/- Emergency Department
Dandenong Hospital
David Street
Dandenong, Vic, 3175
Country [1] 294380 0
Australia
Secondary sponsor category [2] 294385 0
Individual
Name [2] 294385 0
Michaela Mee
Address [2] 294385 0
c/- Emergency Department
Monash Medical Centre
Clayton Road
Clayton, Vic, 3168
Country [2] 294385 0
Australia
Secondary sponsor category [3] 294386 0
Individual
Name [3] 294386 0
Diana Egerton-Warburton
Address [3] 294386 0
c/- Emergency Department
Monash Medical Centre
Clayton Road
Clayton, Vic, 3168
Country [3] 294386 0
Australia
Secondary sponsor category [4] 294387 0
Individual
Name [4] 294387 0
Alastair Meyer
Address [4] 294387 0
c/- Emergency Department
Casey Hospital
Kangan Drive
Berwick, Vic, 3806
Country [4] 294387 0
Australia
Secondary sponsor category [5] 294388 0
Individual
Name [5] 294388 0
Pourya Pouryaha
Address [5] 294388 0
c/- Emergency Department
Casey Hospital
Kangan Drive
Berwick, Vic, 3806
Country [5] 294388 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296880 0
Monash Human Research Ethics Committee
Ethics committee address [1] 296880 0
Research Directorate
Monash Medical Centre
Clayton Road
Clayton, Vic, 3168
Ethics committee country [1] 296880 0
Australia
Date submitted for ethics approval [1] 296880 0
01/12/2016
Approval date [1] 296880 0
05/12/2016
Ethics approval number [1] 296880 0
RES-16-0000-574A

Summary
Brief summary
Study Purpose: Previous ED-based antiemetic research has failed to show a benefit of antiemetic drugs over placebo, with the possible exception of droperidol 1.25 mg IV. This has led to doubts about the value of ED antiemetic drug use, or further ED-based antiemetic research. Recent literature has suggested that the primary outcome measure in the ED-based placebo controlled RCTs to date (comparison of mean VAS change between groups) may not have been sensitive enough to detect true differences. Hence, for this study, an alternate primary outcome measure of VAS reduction in excess of 5 mm is being used, as this cut-off level has been shown to equate with symptom improvement. Study findings should then clarify whether or not antiemetic drugs do have value for ED patients, and may guide future research directions regarding antiemetic drug use in the ED.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72318 0
A/Prof Robert Meek
Address 72318 0
Emergency Department
Dandenong Hospital
David Street
Dandenong, Vic, 3175
Country 72318 0
Australia
Phone 72318 0
+61 3 9554 8475
Fax 72318 0
+61 3 9554 8453
Email 72318 0
robert.meek@monashhealth.org
Contact person for public queries
Name 72319 0
A/Prof Robert Meek
Address 72319 0
Emergency Department
Dandenong Hospital
David Street
Dandenong, Vic, 3175
Country 72319 0
Australia
Phone 72319 0
+61 3 9554 8475
Fax 72319 0
+61 3 9554 8453
Email 72319 0
robert.meek@monashhealth.org
Contact person for scientific queries
Name 72320 0
A/Prof Robert Meek
Address 72320 0
Emergency Department
Dandenong Hospital
David Street
Dandenong, Vic, 3175
Country 72320 0
Australia
Phone 72320 0
+61 3 9554 8475
Fax 72320 0
+61 3 9554 8453
Email 72320 0
robert.meek@monashhealth.org

No information has been provided regarding IPD availability
Summary results
No Results