Skip to content

A RCT of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department

A Randomized Controlled Trial of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00429832
Enrollment
120
Registered
2007-02-01
Start date
2003-10-31
Completion date
2005-11-30
Last updated
2007-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea, Vomiting

Keywords

Nausea, vomiting, antiemetic

Brief summary

This was a trial comparing two commonly used medications for nausea and vomiting, ondansetron and promethazine, in the Emergency Department.

Detailed description

Nausea and vomiting are common complaints in the emergency department (ED). There are many pharmacologic agents used for the treatment of these complaints. None are new nor experimental. Very little research has been done in the ED setting to determine which of these agents is most effective with the least adverse effects. Our own previous research found that droperidol but not prochlorperazine and metoclopramide is more effective than placebo. Because of the recent FDA black box warning added to droperidol, the use of this agent has suddenly ceased in many EDs. Promethazine remains a very commonly used antiemetic in many EDs but one recent study found it less effective than prochlorperazine which was in turn found no more effective than placebo in our own study. As a result many physicians have turned to ondansetron, a newer and more expensive agent. Experience among anesthesiologists and oncologists has shown ondansetron to be highly effective with a minimum of adverse effects. These patient populations, however, are very different from those found in the ED. It is our hypothesis that promethazine and ondansetron are equally effective for the ED treatment of unselected patients with nausea and vomiting with similar rates of adverse effects.

Interventions

DRUGOndansetron

Sponsors

GlaxoSmithKline
CollaboratorINDUSTRY
University of New Mexico
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 18 or older * Chief complaint of nausea or vomiting

Exclusion criteria

* Age less than 18 * unable to provide informed consent * rate nausea at \< 40 mm on 100 mm VAS * received antiemetic within 24 hours * pregnant or possibly pregnant * reported allergy to either study medication * received more than 1 liter of intravenous fluids * their primary ED physician declined to have patient participate

Design outcomes

Primary

MeasureTime frame
Reduction in nausea on a VAS.

Secondary

MeasureTime frame
Change in sedation on a VAS
Change in anxiety on a VAS
Need for rescue medication at 30 minutes
Patient satisfaction at follow-up

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026