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

University of New Mexico (UNM) logo

University of New Mexico (UNM)

Status and phase

Completed
Phase 4

Conditions

Vomiting
Nausea

Treatments

Drug: promethazine
Drug: Ondansetron

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00429832
03-006 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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