Safety Study of Post Tonsillectomy Ibuprofen Use in Adults

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.

Study Overview

• Status: Unknown
• Conditions: Secondary Post Tonsillectomy Hemorrhage; Primary Post Tonsillectomy Hemorrhage
• Intervention / Treatment: Drug: Ibuprofen

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.

• Study Type: Interventional
• Enrollment (Anticipated): 810
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gregory R Dion, MD, MS; Phone Number: 210-916-8040; Email: gregory.r.dion.mil@mail.mil
• Study Contact Backup: Name: Thomas J Willson, MD; Phone Number: 210-916-2367; Email: thomas.j.willson.mil@mail.mil

Study Locations

• United States
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • Recruiting
      • Brooke Army Medical Center
      • Contact: Gregory R Dion, MD, MS; Phone Number: 210-916-8040; Email: gregory.r.dion.mil@mail.mil
      • Principal Investigator: Gregory R Dion, MD, MS
    • Lackland AFB, Texas, United States, 78236
      • Not yet recruiting
      • Wilford Hall Ambulatory Surgical Center
      • Contact: Thomas J Willson, MD; Phone Number: 210-916-2367; Email: thomas.j.willson.mil@mail.mil
      • Principal Investigator: Thomas J Willson, MD
  • Washington
    • Tacoma, Washington, United States, 98431
      • Not yet recruiting
      • Madigan Army Medical Center
      • Contact: Del R Sloneker, MD; Phone Number: 253-968-1420; Email: del.r.sloneker.mil@mail.mil
      • Principal Investigator: Del R Sloneker, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ibuprofen; 800mg ibuprofen every 8 hours prn pain.	Drug: Ibuprofen; 800mg every 8 hours as needed for pain; Other Names: Advil; Motrin
PLACEBO_COMPARATOR: Methylcellulose Powder; Subjects receive inert methylcellulose powder as placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital readmission rate (percentage)		2 weeks
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
Pain scale rating	Subjects will answer a visual analog scale (VAS) Pain scale for days 1, 3, 7, and 14 after tonsillectomy.	2 Weeks
Nausea Scale	Subjects will answer a VAS nausea scale for days 1, 3, and 7 after tonsillectomy.	2 weeks

Collaborators and Investigators

• Sponsor: Brooke Army Medical Center
• Collaborators: 59th Medical Wing; Madigan Army Medical Center; Tripler Army Medical Center; Blanchfield Army Community Hospital
• Investigators: Principal Investigator: Gregory R Dion, MD, MS, San Antonio Military Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (ANTICIPATED): April 1, 2016
• Study Completion (ANTICIPATED): May 1, 2016

Study Registration Dates

• First Submitted: April 18, 2013
• First Submitted That Met QC Criteria: April 18, 2013
• First Posted (ESTIMATE): April 23, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): April 24, 2013
• Last Update Submitted That Met QC Criteria: April 22, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: complications; tonsillectomy; Post tonsillectomy hemorrhage; post operative hemorrhage
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: 384409