Nausea
Conditions
Brief summary
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.
Interventions
DRUGOndansetron
4 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter
DRUGMetoclopramide
10 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter
DRUGPromethazine
12.5 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter
DRUGNormal Saline
Volume matched isotonic sodium chloride solution dose administered over 2 minutes through a peripheral intravenous catheter
Sponsors
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Recruitment details
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
Not applicable to this study
Participants by arm
| Arm | Count |
|---|---|
| Ondansetron Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment | 42 |
| Metoclopramide Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment | 43 |
| Promethazine Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment | 45 |
| Placebo Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment | 41 |
| Total | 171 |
Baseline characteristics
| Characteristic | Metoclopramide | Promethazine | Ondansetron | Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 5 Participants | 3 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 43 Participants | 37 Participants | 38 Participants | 158 Participants |
| Age Continuous | 38.72 years STANDARD_DEVIATION 16.076 | 35.47 years STANDARD_DEVIATION 16.036 | 39.98 years STANDARD_DEVIATION 16.895 | 35.44 years STANDARD_DEVIATION 14.589 | 37.14 years STANDARD_DEVIATION 15.882 |
| Region of Enrollment United States | 43 participants | 45 participants | 42 participants | 41 participants | 171 participants |
| Sex: Female, Male Female | 30 Participants | 31 Participants | 27 Participants | 27 Participants | 115 Participants |
| Sex: Female, Male Male | 13 Participants | 14 Participants | 15 Participants | 14 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 41 | 18 / 40 | 14 / 43 | 9 / 39 |
| serious Total, serious adverse events | 0 / 41 | 0 / 40 | 0 / 43 | 0 / 39 |
Outcome results
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).
Time frame: Baseline and 30 minute assessments
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ondansetron | 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. | -22.0 millimeter |
| Metoclopramide | 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. | -30.0 millimeter |
| Promethazine | 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. | -29.0 millimeter |
| Placebo | 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. | -16.0 millimeter |
Comparison: The null hypothesis is that ondanestron is not more effective in reducing nausea than metoclopramide, promethazine or isotonic normal saline. The sample size was chosen to detect a 12-mm difference in VAS improvement between ondanestron and any other treatment arm (assuming a SD of 25mm) at 90% power and 0.01 alpha significance level. We chose the 0.01 alpha level following a Bonferroni type of correction so that the overall type I error rate is about 0.05.p-value: 0.16Kruskal-Wallis