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Conditional analysis showed observed differences were significantly less than power calculations
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ondansetron | Active Comparator | Ondansetron 4 mg intravenous administration |
|
| Metoclopramide | Active Comparator | Metoclopramide 10 mg intravenous administration |
|
| Promethazine | Active Comparator | Promethazine 10 mg intravenous administration |
|
| Saline Placebo | Placebo Comparator | Volume-matched saline placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron | Drug | 4 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | Baseline and 30 minute assessments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tyler W Barrett, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37240 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20825792 | Result | 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. doi: 10.1016/j.ajem.2009.09.028. Epub 2010 Mar 26. |
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Not applicable to this study
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ondansetron | Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment |
| FG001 | Metoclopramide | Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment |
| FG002 | Promethazine | Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment |
| FG003 | Placebo | Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ondansetron | Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment |
| BG001 | Metoclopramide | Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | 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. | Posted | Median | Inter-Quartile Range | millimeter | Baseline and 30 minute assessments |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ondansetron | Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased Sedation following treatment | General disorders | Systematic Assessment | Patients were asked whether they felt more fatigued or tired. |
Early termination resulted in failure to meet our predetermined sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tyler Barrett | Vanderbilt University | 6159360253 | tyler.barrett@vanderbilt.edu |
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| ID | Term |
|---|---|
| D009325 | Nausea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| D008787 | Metoclopramide |
| D011398 | Promethazine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Metoclopramide | Drug | 10 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter |
|
| Promethazine | Drug | 12.5 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter |
|
| Normal Saline | Drug | Volume matched isotonic sodium chloride solution dose administered over 2 minutes through a peripheral intravenous catheter |
|
| BG002 | Promethazine | Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment |
| BG003 | Placebo | Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Ondansetron | Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment |
| OG001 | Metoclopramide | Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment |
| OG002 | Promethazine | Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment |
| OG003 | Placebo | Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment |
|
|
|
| 0 |
| 41 |
| 10 |
| 41 |
| EG001 | Metoclopramide | Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment | 0 | 40 | 18 | 40 |
| EG002 | Promethazine | Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment | 0 | 43 | 14 | 43 |
| EG003 | Placebo | Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment | 0 | 39 | 9 | 39 |
|
| Pain at iv site following medication administration | Skin and subcutaneous tissue disorders | Systematic Assessment | Patients were asked if they experienced burning at the site of their intravenous catheter following drug administration. |
|
| Headache following treatment | Nervous system disorders | Systematic Assessment | Patients were asked if they experienced a new headache following drug administration? |
|
| Akathisia | General disorders | Systematic Assessment | Patient was asked if they are feeling abnormally restless or fidgety following drug administration? |
|
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| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |
| D011437 | Propylamines |
| D000588 | Amines |
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |