Trial Outcomes & Findings for Ondansetron Versus Dexamethasone/Ondansetron to Treat Acute Nausea in the Emergency Department (NCT NCT02985840)
NCT ID: NCT02985840
Last Updated: 2018-09-26
Results Overview
Effectiveness of intervention will be assessed by the need for additional medications via chart review
TERMINATED
PHASE4
127 participants
1 hour post intervention
2018-09-26
Participant Flow
Participant milestones
| Measure |
Ondansetron
Ondansetron (4 mg) followed by two 5 ml normal saline flush
Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes
|
Ondansetron Plus Dexamethasone
Ondansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush
Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes
Dexamethasone: Patients receive intravenous ondansetron(4mg) followed by intravenous dexamethasone (4mg), followed by a single 5ml normal saline flush
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
63
|
|
Overall Study
COMPLETED
|
64
|
63
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ondansetron
n=64 Participants
Ondansetron (4 mg) followed by two 5 ml normal saline flush
Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes
|
Ondansetron Plus Dexamethasone
n=63 Participants
Ondansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush
Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes
Dexamethasone: Patients receive intravenous ondansetron(4mg) followed by intravenous dexamethasone (4mg), followed by a single 5ml normal saline flush
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.77 years
STANDARD_DEVIATION 11.46 • n=64 Participants
|
34.65 years
STANDARD_DEVIATION 12.75 • n=63 Participants
|
35.21 years
STANDARD_DEVIATION 12.08 • n=127 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=64 Participants
|
43 Participants
n=63 Participants
|
88 Participants
n=127 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=64 Participants
|
20 Participants
n=63 Participants
|
39 Participants
n=127 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
64 Participants
n=64 Participants
|
63 Participants
n=63 Participants
|
127 Participants
n=127 Participants
|
PRIMARY outcome
Timeframe: 1 hour post interventionPopulation: Evaluation of this outcome (need for additional medications within 1 hr of intervention) required additional chart review, which was not performed. As such, this outcome was not collected or analyzed, and cannot be reported.
Effectiveness of intervention will be assessed by the need for additional medications via chart review
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 hour post interventionPopulation: Evaluation of this outcome (resolution of symptoms following intervention) required additional chart review, which was not collected. As such, this outcome was not collected or analyzed, and cannot be reported.
Effectiveness of intervention will be assessed by the resolution of symptoms via chart review
Outcome measures
Outcome data not reported
Adverse Events
Ondansetron
Ondansetron Plus Dexamethasone
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Chelsea Blessing, PhD
OhioHealth Research Institutute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place