Postoperative Ibuprofen Use and Risk of Bleeding in Pediatric Tonsillectomy
Status:
Withdrawn
Trial end date:
2023-01-01
Target enrollment:
Participant gender:
Summary
Pediatric tonsillectomy is one of the most common surgical procedures annually in the United
States; risks include postoperative hemorrhage and poor pain control. Controversy exists
regarding optimal pharmacologic pain management following surgery, as each drug's efficacy is
balanced by its specific side effects. Ibuprofen is effective in controlling postoperative
pain following tonsillectomy, but its mechanism of action results in decreased platelet
function, which may increase postoperative bleeding events. This is a multicenter, randomized
control non-inferiority trial designed to assess the relationship between short-course
ibuprofen use and post-tonsillectomy bleeding when compared to acetaminophen.
Phase:
Phase 1
Details
Lead Sponsor:
Massachusetts Eye and Ear Infirmary
Collaborators:
Emory University Madigan Army Medical Center Rady Children's Hospital, San Diego United States Naval Medical Center, Portsmouth University Hospitals Cleveland Medical Center