Trial Outcomes & Findings for Comparison of Ondansetron, Metoclopramide and Promethazine for the Treatment of Nausea and Vomiting in the Adult ED (NCT NCT00655642)

Last Updated: 2013-10-30

Results Overview

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).

Recruitment status

TERMINATED

Study phase

Target enrollment

171 participants

Primary outcome timeframe

Baseline and 30 minute assessments

Results posted on

2013-10-30

Participant Flow

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.

Not applicable to this study

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	42	43	45	41
Overall Study COMPLETED	41	40	43	39
Overall Study NOT COMPLETED	1	3	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ondansetron n=42 Participants Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment	Metoclopramide n=43 Participants Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment	Promethazine n=45 Participants Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment	Placebo n=41 Participants Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment	Total n=171 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants	40 Participants n=7 Participants	43 Participants n=5 Participants	38 Participants n=4 Participants	158 Participants n=21 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	13 Participants n=21 Participants
Age Continuous	39.98 years STANDARD_DEVIATION 16.895 • n=5 Participants	38.72 years STANDARD_DEVIATION 16.076 • n=7 Participants	35.47 years STANDARD_DEVIATION 16.036 • n=5 Participants	35.44 years STANDARD_DEVIATION 14.589 • n=4 Participants	37.14 years STANDARD_DEVIATION 15.882 • n=21 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	30 Participants n=7 Participants	31 Participants n=5 Participants	27 Participants n=4 Participants	115 Participants n=21 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	13 Participants n=7 Participants	14 Participants n=5 Participants	14 Participants n=4 Participants	56 Participants n=21 Participants
Region of Enrollment United States	42 participants n=5 Participants	43 participants n=7 Participants	45 participants n=5 Participants	41 participants n=4 Participants	171 participants n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ondansetron n=41 Participants Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment	Metoclopramide n=40 Participants Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment	Promethazine n=43 Participants Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment	Placebo n=39 Participants Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment
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 Interval -43.0 to -8.0	-30.0 millimeter Interval -43.5 to -20.0	-29.0 millimeter Interval -46.5 to -9.5	-16.0 millimeter Interval -45.0 to -1.5

Adverse Events

Ondansetron

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Metoclopramide

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Promethazine

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ondansetron n=41 participants at risk Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment	Metoclopramide n=40 participants at risk Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment	Promethazine n=43 participants at risk Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment	Placebo n=39 participants at risk Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment
General disorders Increased Sedation following treatment	7.3% 3/41	30.0% 12/40	25.6% 11/43	15.4% 6/39
Skin and subcutaneous tissue disorders Pain at iv site following medication administration	14.6% 6/41	7.5% 3/40	14.0% 6/43	2.6% 1/39
Nervous system disorders Headache following treatment	4.9% 2/41	5.0% 2/40	2.3% 1/43	10.3% 4/39
General disorders Akathisia	0.00% 0/41	17.5% 7/40	0.00% 0/43	0.00% 0/39

Additional Information

Dr. Tyler Barrett

Vanderbilt University

Phone: 6159360253

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place