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

NCT ID: NCT00429832

Last Updated: 2007-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2005-11-30

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.

Conditions

Nausea; Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Ondansetron

Intervention Type: DRUG

promethazine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

University of New Mexico

OTHER

Sponsor Role: lead

Principal Investigators

Darren A Braude, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

University of New Mexico Hospital Emergency Department

Albuquerque, New Mexico, United States

Countries

United States

References

Braude D, Crandall C. Ondansetron versus promethazine to treat acute undifferentiated nausea in the emergency department: a randomized, double-blind, noninferiority trial. Acad Emerg Med. 2008 Mar;15(3):209-15. doi: 10.1111/j.1553-2712.2008.00060.x.

Reference Type: DERIVED

PMID: 18304050 (View on PubMed)

Other Identifiers

03-006

Identifier Type: -

Identifier Source: org_study_id