Celecoxib as a Post-tonsillectomy Pain Medication

NCT00583453

Last updated date
Study Location
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tonsillitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Celecoxib as a Post-tonsillectomy Pain Medication
Official Title  ICMJE Perioperative Use of Celecoxib to Improve Pain Control in Patients Undergoing Tonsillectomy: a Randomized, Double Blind, Placebo-controlled Trial
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Tonsillitis
Intervention  ICMJE
  • 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
  • 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

Study Arms  ICMJE
  • Active Comparator: A
    Celecoxib 200 mg tablets
    Intervention: Drug: Celecoxib
  • Placebo Comparator: B
    Placebo with same dosing schedule as the active comparator arm
    Intervention: Drug: Placebo
Publications * Van Daele DJ, Bodeker KL, Trask DK. Celecoxib Versus Placebo in Tonsillectomy: A Prospective, Randomized, Double-Blind Placebo-Controlled Trial. Ann Otol Rhinol Laryngol. 2016 Oct;125(10):785-800. doi: 10.1177/0003489416654707. Epub 2016 Jun 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2013)
18
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2007)
56
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00583453
Other Study ID Numbers  ICMJE 200703765
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Data will be uploaded through clinicaltrials.gov data tables
Responsible Party Douglas J Van Daele, University of Iowa
Study Sponsor  ICMJE University of Iowa
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Douglas VanDaele, MDDepartment of Otolaryngology-Head & Neck Surgery
PRS Account University of Iowa
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP