TerminatedPhase 3

Post-operative Course of Dexamethasone to Reduce Tonsillectomy Morbidity

Stopped: slow recruitment

United States222 participantsStarted 2021-08-05

Plain-language summary

The goal of this study is determine if an oral systemic course of steroids is a safe and effective option in lowering pain and complications following adenotonsillectomy in various pediatric age groups. A double blind, placebo-controlled randomized clinical trial of steroids (dexamethasone) versus placebo postoperatively will be performed. Investigators will determine if there is a difference in post-operative pain and complications between groups.

Who can participate

Age range

3 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients age 3 - 17 undergoing adenotonsillectomy meet inclusion criteria Exclusion Criteria: * Patients with Down syndrome * Patients with a history of coagulopathy * Patients with craniofacial abnormalities other than plagiocephaly or submucous cleft palate (SMCP) * Caregivers who cannot speak, read, or write in English proficiently * Patients who take systemic corticosteroids during the enrollment period * Patients who take opioids during the enrollment period * Patients who take chronic opioids * Patients who are pregnant * Patients with allergy to or contraindication for taking any of the study medications * Patients who have the inability to communicate * Patients who have the inability to localize pain * Patients who have type 1 diabetes * Patients who have type 2 diabetes

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Average Pain Over 2-8 Post-operative Days Before Medications

Timeframe: 2-8 days post-operatively

Trial details

NCT IDNCT04879823

SponsorDavid Chi, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-11

Results submitted2024-07-10

View on ClinicalTrials.gov More Adenotonsillectomy trials