Phase 2
N=17
Celecoxib as a Post-tonsillectomy Pain Medication
Tonsillitis
Bottom Line
View on ClinicalTrials.gov: NCT00583453 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Self-reported Pain Score — 5.0; 6.0; 5.1; 6.0 pain score (units on a scale) — p=.674
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Celecoxib (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Iowa
- Primary completion
- Dec 2013
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 |
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.
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
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.