Safety Study of Post Tonsillectomy Ibuprofen Use in Adults



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:April 2013
End Date:May 2016
Contact:Gregory R Dion, MD, MS
Email:gregory.r.dion.mil@mail.mil
Phone:210-916-8040

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

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.

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
We found this trial at
3
sites
9040 Jackson Ave
Tacoma, Washington 98431
(253) 968-1110
Madigan Army Medical Center Located on Joint Base Lewis-McChord, Madigan Army Medical Center comprises a...
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Tacoma, WA
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3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
(210) 916-4141
Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
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Fort Sam Houston, TX
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Lackland AFB, Texas 78236
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Lackland AFB, TX
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