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Celecoxib as a Post-tonsillectomy Pain Medication

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00583453
Recruitment Status : Completed
First Posted : December 31, 2007
Results First Posted : March 29, 2017
Last Update Posted : March 29, 2017
Information provided by (Responsible Party):
Douglas J Van Daele, University of Iowa

Brief 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.

Condition or disease Intervention/treatment Phase
Tonsillitis Drug: Celecoxib Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2007
Actual Primary Completion Date : December 2013
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis
Drug Information available for: Celecoxib

Arm Intervention/treatment
Active Comparator: A
Celecoxib 200 mg tablets
Drug: Celecoxib

Celecoxib 200 mg capsule

  1. capsule the night before surgery
  2. capsules the morning of surgery

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 before surgery
  2. capsules the morning of surgery

1 capsule the night of surgery

1 capsule twice daily for 10 days immediately after the surgery

Primary Outcome Measures :
  1. Self-reported Pain Score [ Time Frame: day of procedure through post-operative day 10 ]
    Pain score as reported by participant, measured on a 10 point scale, where 0 = none and 10 = unbearable, collected once daily.

Secondary Outcome Measures :
  1. Self-reported Activity Level [ Time Frame: From operative day through 10 days post-operative ]
    Activity level, reported by participant utilizing a 10-point ordinal scale (0 = no activity, 10 = return to normal activities). Activity level was measured was collected once daily.

  2. Acetaminophen Equivalent Use [ Time Frame: From operative day through 10 days post-operative ]
    Participant reported acetaminophen use and its equivalent. Medication use was collected from reported participant journals.

  3. Incidence of Post-operative Hemorrhage [ Time Frame: From operative day through 10 days post-operative ]
    The incidence of post-operative hemorrhage, defined as post-operative bleeding requiring medical intervention or hospitalization during the 10 day post-operative follow-up period.

  4. Total Morphine Equivalent [ Time Frame: From operative day through 10 days post-operative ]
    Participant reported mophine equivalent use

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00583453

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United States, Iowa
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
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Principal Investigator: Douglas VanDaele, MD Department of Otolaryngology—Head & Neck Surgery
Publications of Results:
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Responsible Party: Douglas J Van Daele, Associate Professor of Otolaryngology—Head & Neck Surgery, University of Iowa Identifier: NCT00583453    
Other Study ID Numbers: 200703765
First Posted: December 31, 2007    Key Record Dates
Results First Posted: March 29, 2017
Last Update Posted: March 29, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be uploaded through data tables
Keywords provided by Douglas J Van Daele, University of Iowa:
Pain measurement
Additional relevant MeSH terms:
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Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action