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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)
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00655642
First received: April 4, 2008
Last updated: May 9, 2011
Last verified: May 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
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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[1] 1 patient withdrawn by treating physician after consent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
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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
Total Total of all reporting groups

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
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  Other Adverse Events
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  More Information
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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:


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