A Randomised Placebo Controlled Trial of Antiemetic Agents in Adult Emergency Department Patients with Nausea or Vomiting.

Phase 4

• Conditions: ausea; Vomiting; Nausea; Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

• Registration Number: ACTRN12609000549224
• Lead Sponsor: Monash Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 270

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinically significant reduction in nausea as measured by the visual analog scale (VAS).[30 minutes post infusion of study drug]

Secondary Outcome Measures

Name	Time	Method
eed for rescue medication for either nausea or vomiting. <br><br>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.<br>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.[30 minutes post infusion of study drug];Control of vomiting. Vomiting is assessed by staff (nurse or doctor) recording number of emetic episodes seen or reported by patient. <br>An emetic episode is defined as a single vomit/retch or as more than one vomit/retch within one minute of eachother.[30 minutes post infusion of study drug, number of emetic episodes (recorded by nurse or doctor) since commencement of infusion is noted.]