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 range3 Years – 17 Years

SexALL

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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

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