drugset / Trial / NCT04563494

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

NCT04563494 ↗

Phase 4 Completed 127 enrolled University of Colorado, Denver
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2020-10-23
Primary completion
2023-05-24
Completion
2023-05-24

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexamethasone Small molecule 0.5 mg/kg Intravenous

Indications

No indication recorded.