Safety Study of Post Tonsillectomy Ibuprofen Use in Adults

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Secondary Post Tonsillectomy Hemorrhage; Primary Post Tonsillectomy Hemorrhage	Drug: Ibuprofen	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	810 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Supportive Care
Official Title:	NSAID Post-Tonsillectomy Hemorrhage: A Randomized, Double-Blinded Controlled Noninferiority Trial
Study Start Date :	April 2013
Estimated Primary Completion Date :	April 2016
Estimated Study Completion Date :	May 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. Hospital readmission rate (percentage) [ Time Frame: 2 weeks ]
2. 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.
3. 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.
4. Nausea Scale [ Time Frame: 2 weeks ]
   Subjects will answer a VAS nausea scale for days 1, 3, and 7 after tonsillectomy.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Gregory R Dion, MD, MS	210-916-8040	gregory.r.dion.mil@mail.mil
Contact: Thomas J Willson, MD	210-916-2367	thomas.j.willson.mil@mail.mil

Locations

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

Sponsors and Collaborators

Brooke Army Medical Center

Madigan Army Medical Center

Tripler Army Medical Center

Wilford Hall Medical Center

Blanchfield Army Community Hospital

Investigators

Principal Investigator:	Gregory R Dion, MD, MS	San Antonio Military Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Gregory R. Dion, MD, MS, CPT, MC, USA, Brooke Army Medical Center
ClinicalTrials.gov Identifier:	NCT01837810 History of Changes
Other Study ID Numbers:	384409
First Posted:	April 23, 2013
Last Update Posted:	April 24, 2013
Last Verified:	April 2013

Keywords provided by Gregory R. Dion, Brooke Army Medical Center:

Post tonsillectomy hemorrhage; post operative hemorrhage; complications; tonsillectomy

Additional relevant MeSH terms:

Hemorrhage; Pathologic Processes; Ibuprofen; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents	Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action