Trial Outcomes & Findings for Dexamethasone vs Ondansetron After Cesarean Delivery (NCT NCT05692245)
NCT ID: NCT05692245
Last Updated: 2026-03-13
Results Overview
Total number of unscheduled medications administered by nurses to patients and received in the 24 hours after cesarean for the treatment of Nausea, vomiting, pruritus or pain
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
24 hours
Results posted on
2026-03-13
Participant Flow
Participant milestones
| Measure |
Ondansetron
ondansetron 4 mg intravenous, given once after initiation of anesthesia
Ondansetron: Administered Medication
|
Dexamethasone
dexamethasone 8 mg intravenous, given once after initiation of anesthesia
Dexamethasone: Administered Medication
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
48
|
47
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Ondansetron
ondansetron 4 mg intravenous, given once after initiation of anesthesia
Ondansetron: Administered Medication
|
Dexamethasone
dexamethasone 8 mg intravenous, given once after initiation of anesthesia
Dexamethasone: Administered Medication
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
2
|
|
Overall Study
Case cancelled after enrollment
|
0
|
1
|
Baseline Characteristics
Dexamethasone vs Ondansetron After Cesarean Delivery
Baseline characteristics by cohort
| Measure |
Ondansetron
n=48 Participants
ondansetron 4 mg intravenous, given once after initiation of anesthesia
Ondansetron: Administered Medication
|
Dexamethasone
n=47 Participants
dexamethasone 8 mg intravenous, given once after initiation of anesthesia
Dexamethasone: Administered Medication
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.5 years
STANDARD_DEVIATION 4.3 • n=41 Participants
|
36.3 years
STANDARD_DEVIATION 3.5 • n=39 Participants
|
35.4 years
STANDARD_DEVIATION 4.0 • n=80 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=41 Participants
|
47 Participants
n=39 Participants
|
95 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=41 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=41 Participants
|
0 Participants
n=39 Participants
|
7 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=41 Participants
|
47 Participants
n=39 Participants
|
88 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=41 Participants
|
3 Participants
n=39 Participants
|
9 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=41 Participants
|
3 Participants
n=39 Participants
|
6 Participants
n=80 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=41 Participants
|
38 Participants
n=39 Participants
|
74 Participants
n=80 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=41 Participants
|
3 Participants
n=39 Participants
|
6 Participants
n=80 Participants
|
PRIMARY outcome
Timeframe: 24 hoursTotal number of unscheduled medications administered by nurses to patients and received in the 24 hours after cesarean for the treatment of Nausea, vomiting, pruritus or pain
Outcome measures
| Measure |
Ondansetron
n=48 Participants
ondansetron 4 mg intravenous, given once after initiation of anesthesia
Ondansetron: Administered Medication
|
Dexamethasone
n=47 Participants
dexamethasone 8 mg intravenous, given once after initiation of anesthesia
Dexamethasone: Administered Medication
|
|---|---|---|
|
Medications Received
|
0.23 Medications
Standard Deviation 0.42
|
0.40 Medications
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: 24 hoursVisual analogue score for Nausea scored on a 10 centimeter line with "No nausea" on the left and "Worst possible nausea" on the right. The minimum score was 0, maximum score was 10, with higher scores represent greater nausea.
Outcome measures
| Measure |
Ondansetron
n=48 Participants
ondansetron 4 mg intravenous, given once after initiation of anesthesia
Ondansetron: Administered Medication
|
Dexamethasone
n=47 Participants
dexamethasone 8 mg intravenous, given once after initiation of anesthesia
Dexamethasone: Administered Medication
|
|---|---|---|
|
Severity of Nausea
|
0 score on a scale
Interval 0.0 to 0.1
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 24 hoursVisual analogue score for Pain scored on a 10 centimeter line with "No pain" on the left and "Worst possible pain" on the right. The minimum score was 0, maximum score was 10, with higher scores represent greater pain.
Outcome measures
| Measure |
Ondansetron
n=48 Participants
ondansetron 4 mg intravenous, given once after initiation of anesthesia
Ondansetron: Administered Medication
|
Dexamethasone
n=47 Participants
dexamethasone 8 mg intravenous, given once after initiation of anesthesia
Dexamethasone: Administered Medication
|
|---|---|---|
|
Severity of Pain
|
3 score on a scale
Interval 2.5 to 4.3
|
2.7 score on a scale
Interval 1.7 to 3.1
|
Adverse Events
Ondansetron
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dexamethasone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place