Postoperative Ibuprofen and the Risk of Bleeding After Tonsillectomy With or Without Adenoidectomy

Completed · Phase 2

Conditions studied: Tonsillectomy, Adenoidectomy

In brief

Tonsillectomy (the surgical removal of the tonsils) is a commonly performed surgery in children. One risk of tonsillectomy is postoperative bleeding, and this can be more dangerous in children because their blood volume is lower than adults. Ibuprofen, a nonsteroidal anti-inflammatory medication (NSAID), is an effective pain medication. Recent guidelines, published by the American Academy of Otolaryngology, advocated use of ibuprofen after tonsillectomy. However, NSAIDs are associated with altered platelet function and a theoretical increased risk of bleeding after surgery. The investigators would like to explore the effect that ibuprofen has on postoperative bleeding, as well as validate previous studies demonstrating it is an effective pain medication after tonsillectomy.

Key facts

Study ID

NCT01605903

Run by

Massachusetts Eye and Ear Infirmary

People needed

741

Starts

2012-05-03

Expected to finish

2017-02-15

Last updated by the study team

2018-04-24

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients ages 2-18 undergoing tonsillectomy with or without adenoidectomy by electrocautery alone for sleep disordered breathing or infectious tonsillitis will be included.
• Patients with complex medical conditions and craniofacial abnormalities will be included.
• Informed consent and child assent will be required for enrollment

You may not qualify if…

• Patients with a known personal or family history of a bleeding disorder will be excluded.
• Patients with a history of asthma, kidney or liver problems will also be excluded.
• 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 will be excluded.
• Patients with allergy to aspirin or other NSAIDs, acetaminophen, Red Dye #40 or Red Dye #33 will also be excluded.
• Pregnancy testing using urine β-subunit of hCG gonadotropin (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 found to be pregnant will be excluded from participation.

Where it is running

• nited States Naval Medical Center, San Diego — San Diego, California, United States
• Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States
• Brook Army Medical Center — San Antonio, Texas, United States
• nited States Naval Medical Center, Portsmouth — Portsmouth, Virginia, United States
• Madigan Army Hospital — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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