Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000549224
Ethics application status
Not yet submitted
Date submitted
18/03/2009
Date registered
7/07/2009
Date last updated
7/07/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Placebo Controlled Trial of Antiemetic Agents in Adult Emergency Department Patients with Nausea or Vomiting.
Scientific title
A Randomised Controlled Trial Comparing Metoclopramide and Ondansetron to Placebo for the Treatment of Nausea and Vomiting in Adult Emergency Department Patients
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nausea 4498 0
Vomiting 4499 0
Condition category
Condition code
Other 4779 4779 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: Ondansetron 4mg intravenous solution infused over 10 minutes
Group 2: Metoclopramide 20mg intravenous solution infused over 10 minutes
Intervention code [1] 4247 0
Treatment: Drugs
Comparator / control treatment
Placebo: normal saline solution 10 ml intravenously infused over 10 minutes
Control group
Placebo

Outcomes
Primary outcome [1] 5639 0
Clinically significant reduction in nausea as measured by the visual analog scale (VAS).
Timepoint [1] 5639 0
30 minutes post infusion of study drug
Secondary outcome [1] 241523 0
Need for rescue medication for either nausea or vomiting.

Rescue medication is offered to the patient if there is no improvement in nausea as per VAS scale OR as per nausea adjectival scale. Likewise it is offered if there is ongoing emetic (vomiting) episodes despite improvement in nausea.
If the patient reports improvement in nausea, the decision to offer rescue medication is at the discretion of the doctor after consultation with the patient.
Timepoint [1] 241523 0
30 minutes post infusion of study drug
Secondary outcome [2] 241524 0
Control of vomiting. Vomiting is assessed by staff (nurse or doctor) recording number of emetic episodes seen or reported by patient.
An emetic episode is defined as a single vomit/retch or as more than one vomit/retch within one minute of eachother.
Timepoint [2] 241524 0
30 minutes post infusion of study drug, number of emetic episodes (recorded by nurse or doctor) since commencement of infusion is noted.

Eligibility
Key inclusion criteria
Patients >18 years of age with primary or secondary complaint of nausea with or without vomiting who present to the Emergency Department (ED) and require intravenous antiemetic medication.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known allergy to any of the trial agents.
Mild Nausea as rated by patient
Use of agent with known antiemetic properties in the 8 hours prior to ED presentation (see list of medications with known antiemetic properties).
Patients who are too unwell to consent or participate i.e. Cardiovascular instability, hepatic failure, renal failure or very severe nausea or vomiting.
Use of any agent with known antiemetic properties or the administration of normal saline infusion during the ED episode of care (prior to consideration for recruitment).
Patients with Parkinson disease or restless leg syndrome.
Patients taking dopamine antagonist.
Patients with cognitive impairment or language barrier, as these situations would not allow outcome measures to be assessed.
Patient with motion related nausea or vertigo.
Pregnancy related nausea or vomiting.
Pregnancy
Patients breast feeding.
Chemotherapy or radiotherapy induced nausea and vomiting (CINV or RINV).

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)
The study will be conducted in Southern Health, Melbourne, Victoria, Australia. This includes three emergency departments: Monash Medical Centre, a tertiary referral hospital; Dandenong Hospital, a major urban hospital; Casey Hospital, a community hospital.
Emergency Physicians and other trained doctors working in the ED will recruit a convenient sample of patients with Emergency Department Nausea or Vomiting (EDNV) that meet the inclusion and exclusion criteria. We will endeavor to flag potential participants using our electronic triage and patient tracking system. This would alert clinicians to potential subjects and also help us retrospectively determine numbers of potential subjects not approached for trial consideration given various constraints of the ED setting.
Pharmacy will receive the randomisation list from the researchers and keep it in a secure place. Pharmacy will allocate study numbers to the randomization list to ensure allocation concealment from researchers. Pharmacy will then prepare identical appearing infusion drugs labeled “anti-emetic study drug-study number___” in sealed, unmarked containers and these will be stored in the Emergency Department pharmacy room fridge. These pre-prepared packs can be stored for 28 days as previously outlined. This supply will ensure minimal delays in administration.
The clinician enrolls a subject and gets their consent. The clinician then administers the next available drug labeled with its study number. The study number is placed on the standardised case report form (CRF) and study prescription.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A permute block method will be used to ensure an equal number of participants in the intervention groups. This will be done using the
Moses-Oakford method for treatment assignment that has been previously described. Using group codes of A-MII, B-OII and C-PII arbitrary block allocation would be performed. A list of random numbers would be obtained from a random number chart. After recording the random numbers a final block order and thus randomisation list would be produced.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
270
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1560 0
3168

Funding & Sponsors
Funding source category [1] 4686 0
Hospital
Name [1] 4686 0
Southern Health, Monash Medical Centre, Emergency Department
Country [1] 4686 0
Australia
Funding source category [2] 237266 0
Hospital
Name [2] 237266 0
Southern Health, Monash Medical Centre,
Country [2] 237266 0
Australia
Primary sponsor type
Hospital
Name
Monash Medical Centre
Address
246 Clayton Rd, Clayton, VIC, 3168
Country
Australia
Secondary sponsor category [1] 236751 0
Hospital
Name [1] 236751 0
Dandenong Hospital
Address [1] 236751 0
David Street, Dandenong, VIC, 3175
Country [1] 236751 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6724 0
Ethics committee address [1] 6724 0
Ethics committee country [1] 6724 0
Date submitted for ethics approval [1] 6724 0
18/03/2009
Approval date [1] 6724 0
Ethics approval number [1] 6724 0

Summary
Brief summary
Many patients present to emergency departments with nausea and vomiting. There are many possible causes of nausea and vomiting, such as gastroenteritis, side effects of medications, or surgical conditions to name a few. Because of its many causes, emergency department nausea and vomiting is difficult to study and treat. Drugs used to treat nausea and vomiting are called antiemetics.
Very few studies of emergency department nausea and vomiting have been performed. Evidence from other areas of medicine, including cancer and postoperative research, has been used to determine what drugs are used in the emergency department setting. The patients in such research however are different to emergency department patients, and so it is not possible to reliably transfer the evidence.
We propose to study two drugs used in the emergency department for nausea and vomiting. We will compare them to each other and also to placebo (an inactive injection that looks the same as the study drugs). These two drugs are called metoclopramide and ondansetron.
It is possible that the drugs currently used in emergency departments for nausea and vomiting are not more effective than placebo (inactive drug). Given that these drugs have side effects, it is important to find out if they work.
To make sure patients are not potentially disadvantaged by getting placebo, I have excluded patients with very severe nausea or vomiting from this study. Also, if patients still have nausea or vomiting after 45 minutes from the start of treatment, they can get a “rescue” medication of intermediate dose Ondansetron.
Since the two active drugs studied are well proven to work in patients with nausea or vomiting due to cancer therapies or post surgical patients, I have also excluded such patients from this study.
Everybody involved in the trial will be blinded (not know which drug the subject is getting). The subject will be randomly allocated to which treatment they will get. This will help to ensure the results and conclusions are accurate.
Subject response to the study drugs will be compared to each other and to placebo (inactive drug) to see which is the best drug for the treatment of emergency department nausea and vomiting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29413 0
Address 29413 0
Country 29413 0
Phone 29413 0
Fax 29413 0
Email 29413 0
Contact person for public queries
Name 12660 0
Dr. Michaela Mee
Address 12660 0
Emergency Department, Monash Medical Centre, 246 Clayton Road, Clayton, VIC 3168
Country 12660 0
Australia
Phone 12660 0
+61 3 9594 6666
Fax 12660 0
Email 12660 0
mmee@iprimus.com.au
Contact person for scientific queries
Name 3588 0
Dr. Michaela Mee
Address 3588 0
Emergency Department, Monash Medical Centre, 246 Clayton Road, Clayton, VIC 3168
Country 3588 0
Australia
Phone 3588 0
+61 3 9594 6666
Fax 3588 0
Email 3588 0
mmee@iprimus.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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