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Cheaper, Needle-Free option for Post-Surgery nausea in children put to the test

NCT ID NCT04563494

Symptom relief Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 29, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This trial tests whether giving dexamethasone as a pill works just as well as an IV injection to prevent nausea and vomiting after tonsillectomy in children aged 3 to 7. The study also looks at pain levels and drug costs. If oral dexamethasone proves non-inferior, it could offer a simpler, lower-cost alternative during IV drug shortages.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dexamethasone given by mouth or by IV
What this could lead to
If oral dexamethasone works as well as the IV form, it could offer a cheaper, easier way to prevent post-surgery nausea and vomiting in children.
What could go wrong
This is a small, single-center trial. Oral dexamethasone may not be as effective as IV, and results may not apply to all children or surgeries.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

126 people

The number who actually took part.

Started

Oct 2020

Finished

May 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 7 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 3-7 years of age * tonsillectomy with or without adenoidectomy and tympanostomy tube placement Exclusion Criteria: * Subjects receiving one week before surgery: •-antiemetics * steroids * anti-histaminic * psychoactive drugs

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Conditions

The condition(s) this trial relates to.

Postoperative Nausea and Vomiting

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nausea and vomiting, postoperative

Contacts and locations

Locations

  • Children's Hospital of Colorado

    Aurora, Colorado, 80045, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.