Celecoxib as a Post-tonsillectomy Pain Medication

Study Overview
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Brief Summary
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The hypothesis is that celecoxib effectively reduces pain after a tonsillectomy and reduces post-operative narcotic use. To test this hypothesis, the study is placebo controlled (sugar pill). Half of the participants will receive a sugar pill, half will not. All participants will receive the standard post-operative pain medications. We ask participants to log the amount of medications they use daily, and the amount of pain they have each day. It is hoped that celecoxib will reduce the amount of post-operative pain medication needed.

Detailed Description
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Post-tonsillectomy pain is typically controlled through narcotic medications, such as Lortab elixir. Despite its standard use, this pain control is typically not as effective as a non-steroidal anti-inflammatory medication (NSAID). The problem with using NSAIDs for post-tonsillectomy operative pain is the significant increased risk of rebleeding. Celecoxib is an NSAID that is a COX-2 inhibitor; the drug is designed to act as an NSAID without the increased risk of rebleeding or hemorrhage. This study is a double blind, randomized study; neither the study participant or the study investigator knows if the participant is receiving celecoxib or a placebo (sugar pill). The blinded list is maintained by the research pharmacists and can be unblinded when needed (such as in an emergency). Participants begin taking the study medication the night before surgery and continue through 10 days post-operative. Participants are asked to complete a journal that catalogs the amount of standard post-operative medications taken, the amount of pain experienced, and any other comments. Participants are contacted by phone at 5 and 10 days post-op. Study participation ends at the standard 3-week post-operative check-up.

Official Title
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Perioperative Use of Celecoxib to Improve Pain Control in Patients Undergoing Tonsillectomy: a Randomized, Double Blind, Placebo-controlled Trial

Conditions
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Tonsillitis

Intervention / Treatment
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* Drug: Celecoxib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age at least 18 years Indication for tonsillectomy (patients undergoing a tonsillectomy as a portion of additional surgical procedures will not be included) Have the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: History of bleeding disorders History of liver or kidney dysfunction History of allergy to sulfa containing medications History of lactose intolerance History of asthma, urticaria, or allergic-type reactions to aspirin or NSAIDs Women who are currently pregnant, nursing, or trying to conceive History of allergy or intolerance to acetaminophen or hydrocodone History of allergy to any COX-2 inhibitor, including celecoxib or rofecoxib. PT, PTT, hemoglobin, or hematocrit values that are outside of institutional limits. History of cardiovascular disease Patients currently taking celecoxib

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Celecoxib 200 mg tablets | Drug: Celecoxib<br>* Celecoxib 200 mg capsule capsule the night before surgery capsules the morning of surgery 1 capsule the night of surgery 1 capsule twice daily for 10 days immediately after the surgery<br>* Other names: Celebrex;|
| Placebo Comparator: B<br>Placebo with same dosing schedule as the active comparator arm | Drug: Placebo<br>* Placebo capsule capsule the night before surgery capsules the morning of surgery 1 capsule the night of surgery 1 capsule twice daily for 10 days immediately after the surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported Pain Score | Pain score as reported by participant, measured on a 10 point scale, where 0 = none and 10 = unbearable, collected once daily. | day of procedure through post-operative day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported Activity Level | Activity level, reported by participant utilizing a 10-point ordinal scale (0 = no activity, 10 = return to normal activities). Activity level was measured was collected once daily. | From operative day through 10 days post-operative | 
| Acetaminophen Equivalent Use | Participant reported acetaminophen use and its equivalent. Medication use was collected from reported participant journals. | From operative day through 10 days post-operative | 
| Incidence of Post-operative Hemorrhage | The incidence of post-operative hemorrhage, defined as post-operative bleeding requiring medical intervention or hospitalization during the 10 day post-operative follow-up period. | From operative day through 10 days post-operative | 
| Total Morphine Equivalent | Participant reported mophine equivalent use | From operative day through 10 days post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tonsillectomy, Analgesia, Pain measurement, Celecoxib