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COMPLETED
NCT04563494
PHASE4

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

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

Summary

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.

Official title: The Effects of IV vs Oral Dexamethasone on Postoperative Nausea, Vomiting, Pain, and Drug Cost in Children Undergoing Tonsillectomy: A Randomized Controlled Prospective Non-inferiority Study

Key Details

Gender

All

Age Range

3 Years - 7 Years

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2020-10-23

Completion Date

2023-05-24

Last Updated

2026-08-28

Healthy Volunteers

No

Interventions

DRUG

dexamethasone

Prevention of post op nausea and vomiting

Locations (1)

Children's Hospital of Colorado

Aurora, Colorado, United States