Postoperative Ibuprofen Use and Risk of Bleeding in Pediatric Tonsillectomy

• Status: Withdrawn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

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Acetaminophen; Ibuprofen

Criteria

Inclusion Criteria:

• Male and female patients ages 2-18 undergoing tonsillectomy with or without adenoidectomy by electrocautery alone for all indications

• Patients with complex medical conditions and craniofacial abnormalities will be included.

• Family must understand and be able to read English.

• Only patients who are not pregnant will be included.

• Informed consent and, child assent (when appropriate) will be required for enrollment. Patients will provide signed and dated informed consent form.

• Subjects will be willing and able to comply with all study procedures and be available for the duration of the study.

Exclusion Criteria:

• Patients with a known personal or family history of a bleeding disorder.

• Patients with a history of asthma, kidney or liver problems.

• Patients with tonsillectomy or adenoidectomy performed using a cold knife technique, microdebrider, coblation or plasma knife.

• Patients on NSAIDs for other medical conditions or those who have taken NSAIDs within 1 week of surgery

• Patients with allergy to aspirin or other NSAIDs, acetaminophen, Red Dye #40 or Red Dye #33

• Patients found to be pregnant will be excluded from participation. Pregnancy testing using urine beta-HCG will be performed on all children > 13 years of age, or those younger than 13 who are menstruating; this is the testing protocol used at the Children's Hospital of Boston.

Patients unwilling to enroll in the study will have the tonsillectomy with or without adenoidectomy performed according to current practice standards.