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

This study has been terminated.

( Conditional analysis showed observed differences were significantly less than power calculations )

Study NCT00655642 Information provided by Vanderbilt University

First Received on April 4, 2008. Last Updated on May 9, 2011 History of Changes

Results First Received: March 21, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Nausea
Interventions:	Drug: Ondansetron Drug: Metoclopramide Drug: Promethazine Drug: Normal Saline

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment started March 2007 and completed October 2008. A covenience sample of all adult patients who presented to the emergency department (ED) with a complaint requiring antiemetic treatment who do not meet the exclusion criteria were considered for enrollment.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Not applicable to this study

Reporting Groups

	Description
Ondansetron	Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment
Metoclopramide	Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment
Promethazine	Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment
Placebo	Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment

Participant Flow: Overall Study

	Ondansetron	Metoclopramide	Promethazine	Placebo
STARTED	42	43	45	41
COMPLETED	41 ^[1]	40 ^[2]	43 ^[3]	39 ^[4]
NOT COMPLETED	1	3	2	2

[1]	1 patient withdrawn by treating physician after consent
[2]	1 patient given drug orally rather than intravenous(iv);1 patient refused iv; 1 pt lost to follow-up
[3]	1 patient left the ED prior to receiving drug; 1 patient's nausea resolved prior to receiving drug
[4]	1 patient's initial Visual analog scale (VAS)<40; 1 patient was withdrawn by treating physician

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Ondansetron	Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment
Metoclopramide	Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment
Promethazine	Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment
Placebo	Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment

Baseline Measures

	Ondansetron	Metoclopramide	Promethazine	Placebo	Total
Number of Participants [units: participants]	42	43	45	41	171
Age [units: participants]
<=18 years	0	0	0	0	0
Between 18 and 65 years	37	40	43	38	158
>=65 years	5	3	2	3	13
Age [units: years] Mean ± Standard Deviation	39.98 ± 16.895	38.72 ± 16.076	35.47 ± 16.036	35.44 ± 14.589	37.14 ± 15.882
Gender [units: participants]
Female	27	30	31	27	115
Male	15	13	14	14	56
Region of Enrollment [units: participants]
United States	42	43	45	41	171

Outcome Measures

1. 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. [ Time Frame: Baseline and 30 minute assessments ]

Show Outcome Measure 1

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination resulted in failure to meet our predetermined sample size.

Results Point of Contact:

Name/Title: Dr. Tyler Barrett
Organization: Vanderbilt University
phone: 6159360253
e-mail: tyler.barrett@vanderbilt.edu

Publications of Results:

Barrett TW, DiPersio DM, Jenkins CA, Jack M, McCoin NS, Storrow AB, Singleton LM, Lee P, Zhou C, Slovis CM. A randomized, placebo-controlled trial of ondansetron, metoclopramide, and promethazine in adults. Am J Emerg Med. 2011 Mar;29(3):247-55. Epub 2010 Mar 26.

Responsible Party:	Tyler W Barrett, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:	NCT00655642 History of Changes
Other Study ID Numbers:	VUMC 0612369
Study First Received:	April 4, 2008
Results First Received:	March 21, 2011
Last Updated:	May 9, 2011
Health Authority:	United States: Institutional Review Board