Phase 2
Completed N=688
Postoperative Ibuprofen and the Risk of Bleeding After Tonsillectomy With or Without Adenoidectomy
tonsillectomy · Adenoidectomy
Source: ClinicalTrials.gov NCT01605903 ↗
Enrolled (actual)
688
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcomePrimary: Number of Participants With Level 3 Postoperative Hemorrhage — 10; 4 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Level 3 Postoperative Hemorrhage |
10; 4 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01605903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.