The Effects of IV vs Oral Dexamethasone on Postoperative Nausea, Vomiting, and Pain

Completed · Phase 4 · Has a placebo group

Conditions studied: Nausea and Vomiting, Postoperative

In brief

The hypothesis being tested in this study is that perioperative oral administration of dexamethasone, when compared to intravenous (IV) administration, offers a similar reduction in postoperative nausea and vomiting (PONV), and reduction in postoperative pain in pediatric patients undergoing tonsillectomy with or without adenoidectomy and/or tympanostomy tube placement. The specific aim of this study is to demonstrate non-inferiority of oral dexamethasone when compared to IV dexamethasone, given that there is currently a severe, sudden, and world-wide shortage of IV dexamethasone given its recent use in treating patients with covid19 disease.

Key facts

Study ID

NCT04563494

Run by

University of Colorado, Denver

People needed

126

Starts

2020-10-23

Expected to finish

2023-05-24

Last updated by the study team

2026-07-29

Who can join

Age: 3 and older, up to 7. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 3-7 years of age
• tonsillectomy with or without adenoidectomy and tympanostomy tube placement

You may not qualify if…

• Subjects receiving one week before surgery:
• -antiemetics
• steroids
• anti-histaminic
• psychoactive drugs

Where it is running

• Children's Hospital of Colorado — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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