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

Study Primary Completion Date: July 2010

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.

Intervention(s) in this Clinical Trial

• Drug: Celecoxib
  • 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
• Drug: Placebo
  • 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
  • Celecoxib 200 mg tablets
• Placebo Comparator: B
  • Placebo with same dosing schedule as the active comparator arm

Primary Measures

• To compare analgesia in subjects receiving celecoxib versus placebo
  • Time Frame: throughout 10 days post-operative
    Safety Issue?: No

Secondary Measures

• To compare the incidence of post-operative hemorrhage in subjects receiving celecoxib versus placebo
  • Time Frame: operative and 10 days post-operative
    Safety Issue?: 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
  • Time Frame: 3 weeks post-operatively
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Iowa

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 02, 2009

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