ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

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

Vomiting

Condition category

Condition code

Other

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]

Treatment: Drugs

Comparator / control treatment

Placebo: normal saline solution 10 ml intravenously infused over 10 minutes

Control group

Placebo

Outcomes

Primary outcome [1]

Clinically significant reduction in nausea as measured by the visual analog scale (VAS).

Timepoint [1]

30 minutes post infusion of study drug

Secondary outcome [1]

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]

30 minutes post infusion of study drug

Secondary outcome [2]

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]

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?

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]

3168

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Southern Health, Monash Medical Centre, Emergency Department

Address [1]

246 Clayton Rd, Clayton, VIC, 3168

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Southern Health, Monash Medical Centre,

Address [2]

246 Clayton Road, Clayton, VIC, 3168

Country [2]

Australia

Primary sponsor type

Hospital

Name

Monash Medical Centre

Address

246 Clayton Rd, Clayton, VIC, 3168

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Dandenong Hospital

Address [1]

David Street, Dandenong, VIC, 3175

Country [1]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

18/03/2009

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr. Michaela Mee

Address

Emergency Department, Monash Medical Centre, 246 Clayton Road, Clayton, VIC 3168

Country

Australia

Phone

+61 3 9594 6666

Fax

mmee@iprimus.com.au

Contact person for scientific queries

Name

Dr. Michaela Mee

Address

Emergency Department, Monash Medical Centre, 246 Clayton Road, Clayton, VIC 3168

Country

Australia

Phone

+61 3 9594 6666

Fax

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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically