Trial · NCT00655642

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

NCT00655642, Not applicable, Terminated, Vanderbilt University; results first posted 2011-05-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Comparison of Ondansetron, Metoclopramide and Promethazine for the Treatment of Nausea and Vomiting in the Adult ED. Trials, record NCT00655642. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00655642

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Comparison of Ondansetron, Metoclopramide and Promethazine for the Treatment of Nausea and Vomiting in the Adult ED
NCT number: NCT00655642
Status: Terminated
Phases: Not applicable
Enrollment: 171 participants, actual
Lead sponsor: Vanderbilt University
Conditions: Nausea
Interventions: Ondansetron, Metoclopramide, Promethazine, Normal Saline
First posted: 2008-04-10
Last updated: 2013-10-30
Results first posted: 2011-05-09
Limitations and caveats: Early termination resulted in failure to meet our predetermined sample size.

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Visual Analog Scale (VAS) Score for Nausea. This Was Calculated by Subtracting the Patient's Reported Score on the 30 Minute VAS From the Patient's Reported VAS Score on Their Baseline VAS.	Baseline and 30 minute assessments	Participants independently rated their nausea severity on separate scales at the baseline and 30-minute evaluations to prevent the baseline VAS score from influencing the 30-minute mark. The VAS had the words "Least Severe" on the left and "Most Severe" on the right. The possible values range from 0 to 100mm with 0 at the "Least Severe" extreme and 100 at the "Most Severe" extreme. Investigators instructed the participant to draw a single vertical line through the point on the 100mm scale that corresponded to their nausea severity at the times of measurement (Baseline and 30 minutes).

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Visual Analog Scale (VAS) Score for Nausea. This Was Calculated by Subtracting the Patient's Reported Score on the 30 Minute VAS From the Patient's Reported VAS Score on Their Baseline VAS.	Baseline and 30 minute assessments	Analysis was performed on all patients who received one of the four treatments and completed the 30-minute VAS assessment. The trial was anticipated to require 18 months to achieve full accrual of patients (n=600). Given that we were at 30% information fraction at 17 months, an unplanned interim analysis was done.	millimeter	MEDIAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Visual Analog Scale (VAS) Score for Nausea. This Was Calculated by Subtracting the Patient's Reported Score on the 30 Minute VAS From the Patient's Reported VAS Score on Their Baseline VAS.	Ondansetron	-22.0	Inter-Quartile Range -43.0 to -8.0	millimeter
Change in Visual Analog Scale (VAS) Score for Nausea. This Was Calculated by Subtracting the Patient's Reported Score on the 30 Minute VAS From the Patient's Reported VAS Score on Their Baseline VAS.	Metoclopramide	-30.0	Inter-Quartile Range -43.5 to -20.0	millimeter
Change in Visual Analog Scale (VAS) Score for Nausea. This Was Calculated by Subtracting the Patient's Reported Score on the 30 Minute VAS From the Patient's Reported VAS Score on Their Baseline VAS.	Promethazine	-29.0	Inter-Quartile Range -46.5 to -9.5	millimeter
Change in Visual Analog Scale (VAS) Score for Nausea. This Was Calculated by Subtracting the Patient's Reported Score on the 30 Minute VAS From the Patient's Reported VAS Score on Their Baseline VAS.	Placebo	-16.0	Inter-Quartile Range -45.0 to -1.5	millimeter

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ondansetron	42
Overall Study	STARTED	Metoclopramide	43
Overall Study	STARTED	Promethazine	45
Overall Study	STARTED	Placebo	41
Overall Study	COMPLETED	Ondansetron	41
Overall Study	COMPLETED	Metoclopramide	40
Overall Study	COMPLETED	Promethazine	43
Overall Study	COMPLETED	Placebo	39
Overall Study	NOT COMPLETED	Ondansetron	1
Overall Study	NOT COMPLETED	Metoclopramide	3

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Increased Sedation following treatment	General disorders	Ondansetron	3	41
other	Increased Sedation following treatment	General disorders	Metoclopramide	12	40
other	Increased Sedation following treatment	General disorders	Promethazine	11	43
other	Increased Sedation following treatment	General disorders	Placebo	6	39
other	Pain at iv site following medication administration	Skin and subcutaneous tissue disorders	Ondansetron	6	41
other	Pain at iv site following medication administration	Skin and subcutaneous tissue disorders	Metoclopramide	3	40
other	Pain at iv site following medication administration	Skin and subcutaneous tissue disorders	Promethazine	6	43
other	Pain at iv site following medication administration	Skin and subcutaneous tissue disorders	Placebo	1	39
other	Headache following treatment	Nervous system disorders	Ondansetron	2	41
other	Headache following treatment	Nervous system disorders	Metoclopramide	2	40

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ondansetron
Total, all-cause mortality	Metoclopramide
Total, all-cause mortality	Promethazine
Total, all-cause mortality	Placebo
Total, other adverse events	Ondansetron	10	41
Total, other adverse events	Metoclopramide	18	40
Total, other adverse events	Promethazine	14	43
Total, other adverse events	Placebo	9	39
Total, serious adverse events	Ondansetron	0	41
Total, serious adverse events	Metoclopramide	0	40

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20825792	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00655642

GET https://conductscience.org/api/trials/v1/NCT00655642/registered

API reference For AI assistants