Post-operative Course of Dexamethasone to Reduce Tonsillectomy Morbidity

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: David Chi, MD
• Treatments: Acetaminophen; Dexamethasone; Ibuprofen

Criteria

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

• 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