NSAID Post-Tonsillectomy Hemorrhage: A Randomized, Double-Blinded Controlled Noninferiority Trial
Safety Study of Post Tonsillectomy Ibuprofen Use in Adults
Lead sponsor: Brooke Army Medical Center
|Source||Brooke Army Medical Center|
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.
|Overall Status||Unknown status|
|Start Date||April 2013|
|Completion Date||May 2016|
|Primary Completion Date||April 2016|
Intervention type: Drug
Intervention name: Ibuprofen
Description: 800mg every 8 hours as needed for pain
Arm group label: Ibuprofen
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
- Adults 18 years old or older
- Scheduled for tonsillectomy
- 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
Minimum age: 18 Years
Maximum age: N/A
Healthy volunteers: No
Last name: Gregory R Dion, MD, MS
Email: [email protected]
Responsible party type: Principal Investigator
Investigator affiliation: Brooke Army Medical Center
Investigator full name: Gregory R. Dion
Investigator title: MD, MS, CPT, MC, USA
|Has Expanded Access||No|
|Number Of Arms||2|
Arm group label: Ibuprofen
Arm group type: Experimental
Description: 800mg ibuprofen every 8 hours prn pain.
Arm group label: Methylcellulose Powder
Arm group type: Placebo Comparator
Description: Subjects receive inert methylcellulose powder as placebo
|Study Design Info||
Intervention model: Parallel Assignment
Primary purpose: Supportive Care
Masking: Triple (Participant, Care Provider, Investigator)