Safety Study of Post Tonsillectomy Ibuprofen Use in Adults
|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
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|
|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|
800mg ibuprofen every 8 hours prn pain.
800mg every 8 hours as needed for pain
Placebo Comparator: Methylcellulose Powder
Subjects receive inert methylcellulose powder as placebo
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837810
|Contact: Gregory R Dion, MD, MSfirstname.lastname@example.org|
|Contact: Thomas J Willson, MDemail@example.com|
|United States, Texas|
|Brooke Army Medical Center||Recruiting|
|Fort Sam Houston, Texas, United States, 78234|
|Contact: Gregory R Dion, MD, MS 210-916-8040 firstname.lastname@example.org|
|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 email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Del R Sloneker, MD|
|Principal Investigator:||Gregory R Dion, MD, MS||San Antonio Military Medical Center|