Status:
WITHDRAWN
Postoperative Ibuprofen Use and Risk of Bleeding in Pediatric Tonsillectomy
Lead Sponsor:
Massachusetts Eye and Ear Infirmary
Collaborating Sponsors:
Emory University
University Hospitals Cleveland Medical Center
Conditions:
Tonsillectomy With or Without Adenoidectomy
Eligibility:
All Genders
2-18 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
Pediatric tonsillectomy is one of the most common surgical procedures in the United States, with over 500,000 procedures performed annually.1,2 The most common indications for tonsillectomy with and w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03385057
Start Date
September 1 2018
End Date
January 1 2023
Last Update
September 20 2018
Active Locations (5)
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1
Rady's Children's Hospital
San Diego, California, United States, 92123
2
Emory University and Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
3
Case Western University- Raimbow Babies and Children's
Cleveland, Ohio, United States, 44106
4
Portsmouth Naval Hospital
Portsmouth, Virginia, United States, 23708-2197