Safety Study of Post Tonsillectomy Ibuprofen Use in Adults

Study Overview
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Brief Summary
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The purpose of this study is to determine if ibuprofen use after electrocautery tonsillectomy increases the post-tonsillectomy hemorrhage rate. Hypothesis: Use of ibuprofen does not increase the post-tonsillectomy hemorrhage rate. Primary outcome: Rate of tonsillar hemorrhage following adult tonsillectomy in those receiving narcotic pain medications plus ibuprofen compared to those receiving narcotics alone. Secondary outcome: Determine whether ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), decreases post tonsillectomy pain, narcotic pain medication use, or cost of pain management.

Detailed Description
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Tonsillectomy is common procedure associated with significant post-operative pain typically managed by narcotic pain medication. Narcotics, however, can have inherent unwanted side effects such as respiratory depression. In fact, a recent U.S. Food and Drug Administration (FDA) warning has reported deaths from respiratory distress that were associated with use of codeine in children after tonsillectomy. Finding alternative pain management regimens therefore is essential in post-tonsillectomy care. Non-steroidal anti-inflammatory (NSAID) medications may provide an effective alternative to narcotics, but use of NSAIDs routinely after tonsillectomy has been limited due to concern for theoretical increased risk of post-operative bleeding, This is likely true for NSAIDs such as aspirin. NSAIDs such as ibuprofen, however, are believed to have no greater risk of bleeding than baseline, but this has not been proven. Recent, well-designed, prospective pediatric studies have demonstrated effective analgesia improvement with the addition of non-steroidal anti-inflammatory drugs such as ibuprofen to post-operative pain management regimens, and no increased rate of post-surgery bleeding. This has not adequately been studied in adults but could provide many patients significant pain relief in the post-operative period if it is shown to not increase post tonsillectomy hemorrhage rates, as already demonstrated in the pediatric population.

Official Title
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NSAID Post-Tonsillectomy Hemorrhage: A Randomized, Double-Blinded Controlled Noninferiority Trial

Conditions
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Secondary Post Tonsillectomy Hemorrhage, Primary Post Tonsillectomy Hemorrhage

Intervention / Treatment
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* Drug: Ibuprofen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18 years old or older Scheduled for tonsillectomy Exclusion Criteria: Prisoners Pregnancy Allergy to ibuprofen History of vasculopathy to include Lupus or Wegener's or Disseminated Intravascular Coagulation (DIC) Any other bleeding disorder to include Von Willebrand Disease and others Active Neoplasm of any kind Tonsillectomy in combination with any sleep surgical procedure or palatal procedure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibuprofen<br>800mg ibuprofen every 8 hours prn pain. | Drug: Ibuprofen<br>* 800mg every 8 hours as needed for pain<br>* Other names: Motrin;|
| Placebo Comparator: Methylcellulose Powder<br>Subjects receive inert methylcellulose powder as placebo | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinically defined tonsil bleed rate (percentage) | A post tonsillectomy hemorrhage/bleed, for the purposes of this study, is defined as a postoperative bleed requiring anything more than medicinal intervention (cauterization of any kind, suture, evaluation in operating room). | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital readmission rate (percentage) |  | 2 weeks | 
| Subclinical (not requiring intervention) subjectively reported tonsil bleed rate (percentage) | Subjects will report on followup survey if they had post operative oral bleeding more than streaked blood in their spit for which they did not go to the hospital or clinic for treatment of. | 2 weeks | 
| Pain scale rating | Subjects will answer a visual analog scale (VAS) Pain scale for days 1, 3, 7, and 14 after tonsillectomy. | 2 Weeks | 
| Nausea Scale | Subjects will answer a VAS nausea scale for days 1, 3, and 7 after tonsillectomy. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post tonsillectomy hemorrhage, post operative hemorrhage, complications, tonsillectomy