Safety Study of Post Tonsillectomy Ibuprofen Use in Adults
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ClinicalTrials.gov Identifier: NCT01837810 |
Recruitment Status
: Unknown
Verified April 2013 by Gregory R. Dion, Brooke Army Medical Center.
Recruitment status was: Recruiting
First Posted
: April 23, 2013
Last Update Posted
: April 24, 2013
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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 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: Ibuprofen
800mg ibuprofen every 8 hours prn pain.
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Drug: Ibuprofen
800mg every 8 hours as needed for pain
Other Names:
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Placebo Comparator: Methylcellulose Powder
Subjects receive inert methylcellulose powder as placebo
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- 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).
- Hospital readmission rate (percentage) [ Time Frame: 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.
- 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.
- Nausea Scale [ Time Frame: 2 weeks ]Subjects will answer a VAS nausea scale for days 1, 3, and 7 after tonsillectomy.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837810
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 |
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 |
Principal Investigator: | Gregory R Dion, MD, MS | San Antonio Military Medical Center |
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 Key Record Dates |
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 |