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Completed Phase 4 Interventional Results available

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

ClinicalTrials.gov ID: NCT04563494

Public ClinicalTrials.gov record NCT04563494. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 29, 2026, 2:46 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04563494
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Enrollment
126 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
3 Years to 7 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 22, 2020
Primary completion
May 23, 2023
Completion
May 23, 2023
Last update posted
Aug 27, 2026

2020 – 2023

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Children's Hospital of Colorado Aurora Colorado 80045 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04563494, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 27, 2026 · Synced Sep 29, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04563494 live on ClinicalTrials.gov.

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