Safety Study of Post Tonsillectomy Ibuprofen Use in Adults
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.
Secondary Post Tonsillectomy Hemorrhage
Primary Post Tonsillectomy Hemorrhage
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
|Official Title:||NSAID Post-Tonsillectomy Hemorrhage: A Randomized, Double-Blinded Controlled Noninferiority Trial|
- clinically defined tonsil bleed rate (percentage) [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]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).
- Hospital readmission rate (percentage) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Subclinical (not requiring intervention) subjectively reported tonsil bleed rate (percentage) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]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.
- Pain scale rating [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]Subjects will answer a visual analog scale (VAS) Pain scale for days 1, 3, 7, and 14 after tonsillectomy.
- Nausea Scale [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]Subjects will answer a VAS nausea scale for days 1, 3, and 7 after tonsillectomy.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
800mg ibuprofen every 8 hours prn pain.
800mg every 8 hours as needed for pain
Placebo Comparator: Methylcellulose Powder
Subjects receive inert methylcellulose powder as placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01837810
|Contact: Gregory R Dion, MD, MSfirstname.lastname@example.org|
|Contact: Thomas J Willson, MDemail@example.com|
|United States, Texas|
|Brooke Army Medical Center||Recruiting|
|Fort Sam Houston, Texas, United States, 78234|
|Contact: Gregory R Dion, MD, MS 210-916-8040 firstname.lastname@example.org|
|Principal Investigator: Gregory R Dion, MD, MS|
|Wilford Hall Ambulatory Surgical Center||Not yet recruiting|
|Lackland AFB, Texas, United States, 78236|
|Contact: Thomas J Willson, MD 210-916-2367 email@example.com|
|Principal Investigator: Thomas J Willson, MD|
|United States, Washington|
|Madigan Army Medical Center||Not yet recruiting|
|Tacoma, Washington, United States, 98431|
|Contact: Del R Sloneker, MD 253-968-1420 firstname.lastname@example.org|
|Principal Investigator: Del R Sloneker, MD|
|Principal Investigator:||Gregory R Dion, MD, MS||San Antonio Military Medical Center|