Status:
TERMINATED
Post-operative Course of Dexamethasone to Reduce Tonsillectomy Morbidity
Lead Sponsor:
David Chi, MD
Conditions:
Adenotonsillectomy
Analgesia
Eligibility:
All Genders
3-17 years
Phase:
PHASE3
Brief 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 group...
Detailed Description
Purpose: To determine if post-operative dexamethasone is a safe and effective option in the reduction of post-operative pain and morbidity following adenotonsillectomy in various pediatric age groups....
Eligibility Criteria
Inclusion
- Patients age 3 - 17 undergoing adenotonsillectomy meet inclusion criteria
Exclusion
- 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
Key Trial Info
Start Date :
August 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2023
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT04879823
Start Date
August 5 2021
End Date
July 11 2023
Last Update
September 5 2024
Active Locations (2)
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1
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
2
Children's Hospital North Surgery Center
Sewickley, Pennsylvania, United States, 15143