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

Nausea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00429832
• Other study ID #: 03-006
• Status: Completed
• Phase: Phase 4
• First received: January 31, 2007
• Last updated: January 31, 2007
• Start date: October 2003
• Est. completion date: November 2005

Study information

• Verified date: January 2007
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nausea
• Vomiting

Intervention

Drug:
• Ondansetron

• promethazine

Locations

Country	Name	City	State
United States	University of New Mexico Hospital Emergency Department	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in nausea on a VAS.
Secondary	Change in sedation on a VAS
Secondary	Change in anxiety on a VAS
Secondary	Need for rescue medication at 30 minutes
Secondary	Patient satisfaction at follow-up