Safety Study of Post Tonsillectomy Ibuprofen Use in Adults

April 22, 2013 updated by: Gregory R. Dion, Brooke Army Medical Center

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Sam Houston, Texas, United States, 78234
        • Recruiting
        • Brooke Army Medical Center
        • Contact:
        • Principal Investigator:
          • Gregory R Dion, MD, MS
      • Lackland AFB, Texas, United States, 78236
        • Not yet recruiting
        • Wilford Hall Ambulatory Surgical Center
        • Contact:
        • Principal Investigator:
          • Thomas J Willson, MD
    • Washington
      • Tacoma, Washington, United States, 98431
        • Not yet recruiting
        • Madigan Army Medical Center
        • Contact:
        • Principal Investigator:
          • Del R Sloneker, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: 2 weeks
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)
Time Frame: 2 weeks
2 weeks
Subclinical (not requiring intervention) subjectively reported tonsil bleed rate (percentage)
Time Frame: 2 weeks
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
Time Frame: 2 Weeks
Subjects will answer a visual analog scale (VAS) Pain scale for days 1, 3, 7, and 14 after tonsillectomy.
2 Weeks
Nausea Scale
Time Frame: 2 weeks
Subjects will answer a VAS nausea scale for days 1, 3, and 7 after tonsillectomy.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 384409

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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