Postoperative Ibuprofen and the Risk of Bleeding After Tonsillectomy With or Without Adenoidectomy
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|ClinicalTrials.gov Identifier: NCT01605903|
Recruitment Status : Completed
First Posted : May 25, 2012
Last Update Posted : July 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Tonsillectomy Adenoidectomy||Drug: Ibuprofen Drug: Acetaminophen||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||741 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Postoperative Ibuprofen and the Risk of Bleeding After Tonsillectomy With or Without Adenoidectomy|
|Actual Study Start Date :||May 5, 2012|
|Primary Completion Date :||February 15, 2017|
|Study Completion Date :||February 15, 2017|
Experimental: Treatment with Ibuprofen
Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery. 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.
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.
Other Name: Advil, Motrin
Active Comparator: Treatment with Acetaminophen
Children will be randomly assigned to either the treatment arm or active comparator prior to surgery. Children in the active comparator group (Acetaminophen) will receive grape flavored 160 mg/5 ml acetaminophen. Acetaminophen will be dispensed at 15 mg/kg (max dose 650/mg) Q6.
During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6.
Other Name: Tylenol
- Level 3 postoperative hemorrhage [ Time Frame: Data about post-tonsillectomy bleeding will be obtained after the end of a 14-day postoperative period. ]Postoperative hemorrhage is defined as any history of bleeding occurring within the 14 day postoperative period. Hemorrhage will be stratified into 3 levels of severity. Level 1: includes children with a history of postoperative bleeding evaluated and/or treated by a physician in the emergency room, inpatient unit or operating room; Level 2: children requiring inpatient admission for postoperative bleeding regardless of the need for operative intervention; Level 3: children requiring inpatient admission and return to the operating room for control of post-tonsillectomy hemorrhage.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01605903
|United States, California|
|nited States Naval Medical Center, San Diego|
|San Diego, California, United States, 92134|
|United States, Massachusetts|
|Massachusetts Eye and Ear Infirmary|
|Boston, Massachusetts, United States, 02114|
|United States, Texas|
|Brook Army Medical Center|
|San Antonio, Texas, United States, 78219|
|United States, Virginia|
|nited States Naval Medical Center, Portsmouth|
|Portsmouth, Virginia, United States, 23708|
|United States, Washington|
|Madigan Army Hospital|
|Tacoma, Washington, United States, 94831|
|Principal Investigator:||Christopher J Hartnick, MD||Massachusetts Eye and Ear Infirmary|