Clinical trial NCT01837810: Safety Study of Post Tonsillectomy Ibuprofen Use in Adults
Official title: NSAID Post-Tonsillectomy Hemorrhage: A Randomized, Double-Blinded Controlled Noninferiority Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Secondary Post Tonsillectomy Hemorrhage
Primary Post Tonsillectomy Hemorrhage
Keywords: Post tonsillectomy hemorrhage
post operative hemorrhage
complications
tonsillectomy
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
Collaborators: name: Madigan Army Medical Center
name: Tripler Army Medical Center
name: 59th Medical Wing
name: Blanchfield Army Community Hospital
First posted: 2013-04-23
Enrollment: 810
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: clinically defined tonsil bleed rate (percentage)
timeFrame: 2 weeks
Secondary outcomes:
measure: Hospital readmission rate (percentage)
timeFrame: 2 weeks
measure: Subclinical (not requiring intervention) subjectively reported tonsil bleed rate (percentage)
timeFrame: 2 weeks
measure: Pain scale rating
timeFrame: 2 Weeks
measure: Nausea Scale
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Lackland AFB
country: United States
facility: Wilford Hall Ambulatory Surgical Center
state: Texas
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: San Antonio Military Medical Center
name: Gregory R Dion, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: