Celecoxib as a Post-tonsillectomy Pain Medication
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Purpose
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 |
|---|---|---|
|
Tonsillitis |
Drug: Celecoxib Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Perioperative Use of Celecoxib to Improve Pain Control in Patients Undergoing Tonsillectomy: a Randomized, Double Blind, Placebo-controlled Trial |
- To compare analgesia in subjects receiving celecoxib versus placebo [ Time Frame: throughout 10 days post-operative ] [ Designated as safety issue: No ]
- To compare the incidence of post-operative hemorrhage in subjects receiving celecoxib versus placebo [ Time Frame: operative and 10 days post-operative ] [ Designated as 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 56 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Celecoxib 200 mg tablets
|
Drug: Celecoxib
Celecoxib 200 mg capsule
1 capsule the night of surgery 1 capsule twice daily for 10 days immediately after the surgery Other Name: Celebrex
|
|
Placebo Comparator: B
Placebo with same dosing schedule as the active comparator arm
|
Drug: Placebo
Placebo capsule
1 capsule the night of surgery 1 capsule twice daily for 10 days immediately after the surgery |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | 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
Contacts and Locations| United States, Iowa | |
| University of Iowa Hospitals & Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| Principal Investigator: | Douglas VanDaele, MD | Department of Otolaryngology—Head & Neck Surgery |
More Information
No publications provided
| Responsible Party: | Douglas VanDaele, Department of Otolaryngology—Head & Neck Surgery |
| ClinicalTrials.gov Identifier: | NCT00583453 History of Changes |
| Other Study ID Numbers: | 200703765 |
| Study First Received: | December 20, 2007 |
| Last Updated: | July 28, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Iowa:
|
Tonsillectomy Analgesia Pain measurement Celecoxib |
Additional relevant MeSH terms:
|
Tonsillitis Pharyngitis Pharyngeal Diseases Stomatognathic Diseases Respiratory Tract Infections Respiratory Tract Diseases Otorhinolaryngologic Diseases Celecoxib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 23, 2013