Trial Outcomes & Findings for The Effects of IV vs Oral Dexamethasone on Postoperative Nausea, Vomiting, and Pain (NCT NCT04563494)

Results Overview

post-op nausea and vomiting as evidenced by vomiting and/or retching without expulsion of gastric content

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

126 participants

Primary outcome timeframe

4 hours

Results posted on

2026-07-29

Participant Flow

Participant milestones

Participant milestones
Measure	IV Dexmethsone and Oral Placebo dexamethasone: Prevention of post op nausea and vomiting	Oral Dexamethasone and IV Placebo dexamethasone: Prevention of post op nausea and vomiting
Overall Study STARTED	63	63
Overall Study COMPLETED	63	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

Baseline characteristics by cohort
Measure	IV Dexmethsone and Oral Placebo n=63 Participants dexamethasone: Prevention of post op nausea and vomiting	Oral Dexamethasone and IV Placebo n=63 Participants dexamethasone: Prevention of post op nausea and vomiting	Total n=126 Participants Total of all reporting groups
Age, Categorical <=18 years	63 Participants n=63 Participants	63 Participants n=63 Participants	126 Participants n=126 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=63 Participants	0 Participants n=63 Participants	0 Participants n=126 Participants
Age, Categorical >=65 years	0 Participants n=63 Participants	0 Participants n=63 Participants	0 Participants n=126 Participants
Sex: Female, Male Female	35 Participants n=63 Participants	37 Participants n=63 Participants	72 Participants n=126 Participants
Sex: Female, Male Male	28 Participants n=63 Participants	26 Participants n=63 Participants	54 Participants n=126 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	63 participants n=63 Participants	63 participants n=63 Participants	126 participants n=126 Participants

PRIMARY outcome

Timeframe: 4 hours

post-op nausea and vomiting as evidenced by vomiting and/or retching without expulsion of gastric content

Outcome measures

Outcome measures
Measure	IV Dexmethsone and Oral Placebo n=63 Participants dexamethasone: Prevention of post op nausea and vomiting	Oral Dexamethasone and IV Placebo n=63 Participants dexamethasone: Prevention of post op nausea and vomiting
Number of Participants With Post-op Nausea and Vomitting	63 Participants	63 Participants

SECONDARY outcome

Timeframe: 4 hours

Population: The study evaluated whether differences existed between oral and IV dexamethasone.

Number of participants reporting pain

Outcome measures

Outcome measures
Measure	IV Dexmethsone and Oral Placebo n=63 Participants dexamethasone: Prevention of post op nausea and vomiting	Oral Dexamethasone and IV Placebo n=63 Participants dexamethasone: Prevention of post op nausea and vomiting
Number of Participants With Reported Pain	7 Participants	6 Participants

Adverse Events

IV Dexmethsone and Oral Placebo

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Oral Dexamethasone and IV Placebo

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IV Dexmethsone and Oral Placebo n=63 participants at risk dexamethasone: Prevention of post op nausea and vomiting	Oral Dexamethasone and IV Placebo n=63 participants at risk dexamethasone: Prevention of post op nausea and vomiting
Gastrointestinal disorders PONV	14.3% 9/63 • Number of events 9 • 14 Days	7.9% 5/63 • Number of events 5 • 14 Days

Other adverse events

Adverse event data not reported

Additional Information

Jeremy Prager

University of Colorado Denver/Children's Hospital of Colorado

Phone: 720-777-8501

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place