Celecoxib as a Post-tonsillectomy Pain Medication

Phase 2

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
B	Placebo	Placebo with same dosing schedule as the active comparator arm
A	Celecoxib	Celecoxib 200 mg tablets

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Self-reported Activity Level	From operative day through 10 days post-operative	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.
Incidence of Post-operative Hemorrhage	From operative day through 10 days post-operative	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.
Total Morphine Equivalent	From operative day through 10 days post-operative	Participant reported mophine equivalent use
Acetaminophen Equivalent Use	From operative day through 10 days post-operative	Participant reported acetaminophen use and its equivalent. Medication use was collected from reported participant journals.