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

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.

Study Type: Interventional

Study Design: Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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.

Primary:

• To compare analgesia in subjects receiving celecoxib versus placebo throughout 10 days post-operative No

Secondary:

• To compare the incidence of post-operative hemorrhage in subjects receiving celecoxib versus placebo operative and 10 days post-operative Yes
• To compare the number of days of leave from work or school that subjects need in the postoperative period in subjects receiving celecoxib versus placebo 3 weeks post-operatively No

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

Lead Sponsor: University of Iowa

University of Iowa Hospitals & Clinics

Iowa City Iowa 52242 United States

Overall Clinical Trial Officials and Contacts

Douglas K. Trask, MD PhD FACS Principal Investigator Department of Otolaryngology—Head & Neck Surgery  

Overall Contact: Jane Hershberger, R.N. (319) 353-8973 jane-hershberger@uiowa.edu

Information obtained from ClinicalTrials.gov on July 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00583453

Study ID Number: 200703765

ClinicalTrials.gov Identifier: NCT00583453

Health Authority: United States: Institutional Review Board