Comparison of Ondansetron, Metoclopramide and Promethazine for the Treatment of Nausea and Vomiting in the Adult ED

Vanderbilt University

Status: Terminated

Conditions: Nausea

Treatments: Drug: Normal Saline; Drug: Promethazine; Drug: Metoclopramide; Drug: Ondansetron

Study type: Interventional

Funder types: Other

Identifiers

NCT00655642

VUMC 0612369

Details and patient eligibility

About

The purpose of this study is to compare the effectiveness of ondansetron, metoclopramide, and promethazine for the treatment of nausea in the adult emergency department population.

We hypothesize that a single intravenous dose of ondansetron is more effective in reducing nausea than a single IV dose of metoclopramide, promethazine or normal saline placebo in undifferentiated adult emergency department patients.

Enrollment: 171 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients age 18 or older who present to the ED with a complaint requiring antiemetic treatment who do not meet the exclusion criteria.

Exclusion criteria

• Patients less than 18 years of age
• Unstable patients with SBP < 90
• Patients with a stated or documented allergy to any of the study medications
• Patients whose nausea rating if < 40 on the pretreatment VAS scale
• Patients who have received a commonly accepted antiemetic within the previous 24 hours
• Patients unwilling or unable to complete the assessment tool before and 30 minutes after study drug dosing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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171 participants in 4 patient groups, including a placebo group

Ondansetron

Active Comparator group

Description:

Ondansetron 4 mg intravenous administration

Treatment:

Drug: Ondansetron

Metoclopramide

Active Comparator group

Description:

Metoclopramide 10 mg intravenous administration

Treatment:

Drug: Metoclopramide

Promethazine

Active Comparator group

Description:

Promethazine 10 mg intravenous administration

Treatment:

Drug: Promethazine

Saline Placebo

Placebo Comparator group

Description:

Volume-matched saline placebo

Treatment:

Drug: Normal Saline