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

Safety Study of Post Tonsillectomy Ibuprofen Use in Adults

Sponsors

Lead sponsor: Brooke Army Medical Center

Collaborator: Madigan Army Medical Center
Tripler Army Medical Center
59th Medical Wing
Blanchfield Army Community Hospital

Source Brooke Army Medical Center
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.

Overall Status Unknown status
Start Date April 2013
Completion Date May 2016
Primary Completion Date April 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
clinically defined tonsil bleed rate (percentage) 2 weeks
Secondary Outcome
Measure Time Frame
Hospital readmission rate (percentage) 2 weeks
Subclinical (not requiring intervention) subjectively reported tonsil bleed rate (percentage) 2 weeks
Pain scale rating 2 Weeks
Nausea Scale 2 weeks
Enrollment 810
Condition
Intervention

Intervention type: Drug

Intervention name: Ibuprofen

Description: 800mg every 8 hours as needed for pain

Arm group label: Ibuprofen

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Gregory R Dion, MD, MS Principal Investigator San Antonio Military Medical Center
Overall Contact

Last name: Gregory R Dion, MD, MS

Phone: 210-916-8040

Email: [email protected]

Location
facility status contact investigator
Brooke Army Medical Center | Fort Sam Houston, Texas, 78234, United States Recruiting Gregory R Dion, MD, MS 210-916-8040 [email protected] Gregory R Dion, MD, MS Principal Investigator
Wilford Hall Ambulatory Surgical Center | Lackland AFB, Texas, 78236, United States Not yet recruiting Thomas J Willson, MD 210-916-2367 [email protected] Thomas J Willson, MD Principal Investigator
Madigan Army Medical Center | Tacoma, Washington, 98431, United States Not yet recruiting Del R Sloneker, MD 253-968-1420 [email protected] Del R Sloneker, MD Principal Investigator
Location Countries

United States

Verification Date

April 2013

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Brooke Army Medical Center

Investigator full name: Gregory R. Dion

Investigator title: MD, MS, CPT, MC, USA

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

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

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov