Postoperative Ibuprofen and the Risk of Bleeding After Tonsillectomy With or Without Adenoidectomy
Condition: Tonsillectomy; Adenoidectomy
MeSH terms: Hemorrhage
Intervention: Ibuprofen; Acetaminophen
Intervention description: Children in the ibuprofen group will be receive grape-flavored ibuprofen 100mg/5 mL. During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6.; During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6.
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 741.0
Sex: All
Minimum age: 2 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Tonsillectomy; adenoidectomy; bleeding; bleeding rates; Tonsillectomy with and without adenoidectomy

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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.