Phase 2 Completed N=17 Randomized Quadruple-blind Supportive Care

Celecoxib as a Post-tonsillectomy Pain Medication

tonsillitis

Source: ClinicalTrials.gov NCT00583453 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2017

Primary outcomePrimary: Self-reported Pain Score — 5.0; 6.0; 5.1; 6.0 pain score (units on a scale) — p=.674

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Self-reported Pain Score	5.0; 6.0; 5.1; 6.0; 4.4; 5.9	.674
SECONDARY Self-reported Activity Level	2.8; 4.5; 3.1; 4.1; 5.4; 3.7	0.018 sig
SECONDARY Acetaminophen Equivalent Use	2074; 3006; 2245; 2934; 2028; 3610	.214
SECONDARY Incidence of Post-operative Hemorrhage	0; 0	—
SECONDARY Total Morphine Equivalent	28.9; 55.0; 30.4; 72.4; 27.8; 69.7	0.036 sig

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT00583453). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.