Postoperative Ibuprofen Use and Risk of Bleeding in Pediatric Tonsillectomy (NCT03385057) | Clinical Trial Compass
WithdrawnPhase 1
Postoperative Ibuprofen Use and Risk of Bleeding in Pediatric Tonsillectomy
Stopped: Study design flaws; research design needed to be reconfigured
United States0Started 2018-09
Plain-language 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 pharmacologic pain management following surgery, as each drug's efficacy is balanced by its specific side effects. Ibuprofen is effective in controlling postoperative pain following tonsillectomy, but its mechanism of action results in decreased platelet function, which may increase postoperative bleeding events. This is a multicenter, randomized control non-inferiority trial designed to assess the relationship between short-course ibuprofen use and post-tonsillectomy bleeding when compared to acetaminophen.
Who can participate
Age range
2 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Post-tonsillectomy bleeding within 14 days of surgery.