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Sponsors and Collaborators: |
University of Iowa Pfizer |
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Information provided by: | University of Iowa |
ClinicalTrials.gov Identifier: | NCT00583453 |
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.
Condition | Intervention | Phase |
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Tonsillitis |
Drug: Celecoxib Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Perioperative Use of Celecoxib to Improve Pain Control in Patients Undergoing Tonsillectomy: a Randomized, Double Blind, Placebo-Controlled Trial |
Estimated Enrollment: | 56 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Celecoxib 200 mg tablets
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Drug: Celecoxib
Celecoxib 200 mg capsule
1 capsule the night of surgery 1 capsule twice daily for 10 days immediately after the surgery |
B: Placebo Comparator
Placebo with same dosing schedule as the active comparator arm
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Drug: Placebo
Placebo capsule
1 capsule the night of surgery 1 capsule twice daily for 10 days immediately after the surgery |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jane Hershberger, R.N. | (319) 353-8973 | jane-hershberger@uiowa.edu |
Contact: Kellie Bodeker, B.Sc, CCRC | (319) 384-9425 | kellie-bodeker@uiowa.edu |
United States, Iowa | |
University of Iowa Hospitals & Clinics | Recruiting |
Iowa City, Iowa, United States, 52242 | |
Principal Investigator: Douglas K. Trask, MD PhD FACS |
Principal Investigator: | Douglas K. Trask, MD PhD FACS | Department of Otolaryngology—Head & Neck Surgery |
Responsible Party: | Department of Otolaryngology—Head & Neck Surgery ( Douglas K. Trask, MD, Ph.D., FACS ) |
Study ID Numbers: | 200703765 |
Study First Received: | December 20, 2007 |
Last Updated: | June 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00583453 |
Health Authority: | United States: Institutional Review Board |
Tonsillectomy Analgesia Pain measurement Celecoxib |
Celecoxib Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Tonsillitis Pain Stomatognathic Diseases Pharyngeal Diseases |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Physiological Effects of Drugs Enzyme Inhibitors Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |