Safety Study of Post Tonsillectomy Ibuprofen Use in Adults

Primary Post Tonsillectomy Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01837810
• Other study ID #: 384409
• Status: Recruiting
• Phase: N/A
• First received: April 18, 2013
• Last updated: April 22, 2013
• Start date: April 2013
• Est. completion date: May 2016

Study information

• Verified date: April 2013
• Source: Brooke Army Medical Center
• Contact: Gregory R Dion, MD, MS
• Phone: 210-916-8040
• Email: gregory.r.dion.mil[@]mail.mil
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 810
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hemorrhage
• Primary Post Tonsillectomy Hemorrhage
• Secondary Post Tonsillectomy Hemorrhage

Intervention

Drug:
• Ibuprofen
800mg every 8 hours as needed for pain

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	Wilford Hall Ambulatory Surgical Center	Lackland AFB	Texas
United States	Madigan Army Medical Center	Tacoma	Washington

Sponsors (5)

Lead Sponsor	Collaborator
Brooke Army Medical Center	Blanchfield Army Community Hospital, Madigan Army Medical Center, Tripler Army Medical Center, Wilford Hall Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	2 weeks	Yes
Secondary	Hospital readmission rate (percentage)		2 weeks	No
Secondary	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.	2 weeks	No
Secondary	Pain scale rating	Subjects will answer a visual analog scale (VAS) Pain scale for days 1, 3, 7, and 14 after tonsillectomy.	2 Weeks	No
Secondary	Nausea Scale	Subjects will answer a VAS nausea scale for days 1, 3, and 7 after tonsillectomy.	2 weeks	No