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

NCT04563494 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 20-1742
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nausea and Vomiting, Postoperative

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Post-op Nausea and Vomitting

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

  4 hours

Secondary Outcomes (1)

• Number of Participants With Reported Pain

  4 hours

Study Arms (2)

IV Dexmethsone and oral placebo

ACTIVE COMPARATOR

Drug: dexamethasone

Oral dexamethasone and IV placebo

ACTIVE COMPARATOR

Drug: dexamethasone

Interventions

dexamethasone DRUG

Prevention of post op nausea and vomiting

IV Dexmethsone and oral placebo; Oral dexamethasone and IV placebo

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Jeremy Prager
• Organization: University of Colorado Denver/Children's Hospital of Colorado

Jeremy.prager@childrenscolorado.org

720-777-8501

Study Officials

• Melissa Brooks Peterson, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 24, 2020
• Study Start: October 23, 2020
• Primary Completion: May 24, 2023
• Study Completion: May 24, 2023
• Last Updated: July 29, 2026
• Results First Posted: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)