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Completed

NCT Number: NCT00429832

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of New Mexico Hospital Emergency Department

Albuquerque, New Mexico, 87131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ondansetron

Drug

Promethazine

Drug

Primary outcomes

  1. Reduction in nausea on a VAS.

Secondary outcomes

  1. Change in sedation on a VAS

  2. Change in anxiety on a VAS

  3. Need for rescue medication at 30 minutes

  4. Patient satisfaction at follow-up

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2005
First posted
Feb 1, 2007
Registry last updated
Feb 1, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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