An interventional study of Ibuprofen in Secondary Post Tonsillectomy Hemorrhage and Primary Post Tonsillectomy Hemorrhage, sponsored by Brooke Army Medical Center. Status unknown at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-04-24.
Sponsored by Brooke Army Medical Center · Not applicable, Interventional, and Supportive care
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.
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's planned enrollment of 810 is above the median of 100 across 1,985 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →Brooke Army Medical Center is the lead sponsor of 92 studies on the registry; 11 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 2 (25%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
800mg ibuprofen every 8 hours prn pain.
Drug: Ibuprofen
Subjects receive inert methylcellulose powder as placebo
800mg every 8 hours as needed for pain
Also known as: Advil, Motrin
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).
Time frame: 2 weeks
Hospital readmission rate (percentage)
Time frame: 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.
Time frame: 2 weeks
Pain scale rating
Subjects will answer a visual analog scale (VAS) Pain scale for days 1, 3, 7, and 14 after tonsillectomy.
Time frame: 2 Weeks
Nausea Scale
Subjects will answer a VAS nausea scale for days 1, 3, and 7 after tonsillectomy.
Time frame: 2 weeks
This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Brooke Army Medical Center