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| Name | Class |
|---|---|
| Madigan Army Medical Center | FED |
| Tripler Army Medical Center | FED |
| 59th Medical Wing | FED |
| Blanchfield Army Community Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen | Experimental | 800mg ibuprofen every 8 hours prn pain. |
|
| Methylcellulose Powder | Placebo Comparator | Subjects receive inert methylcellulose powder as placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | 800mg every 8 hours as needed for pain |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gregory R Dion, MD, MS | Contact | 210-916-8040 | gregory.r.dion.mil@mail.mil | |
| Thomas J Willson, MD | Contact | 210-916-2367 | thomas.j.willson.mil@mail.mil |
| Name | Affiliation | Role |
|---|---|---|
| Gregory R Dion, MD, MS | San Antonio Military Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooke Army Medical Center | Recruiting | Fort Sam Houston | Texas | 78234 | United States |
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| ID | Term |
|---|---|
| D019106 | Postoperative Hemorrhage |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| FED |
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| 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 |
| Wilford Hall Ambulatory Surgical Center | Not yet recruiting | Lackland Air Force Base | Texas | 78236 | United States |
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| Madigan Army Medical Center | Not yet recruiting | Tacoma | Washington | 98431 | United States |
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