Celecoxib as a Post-tonsillectomy Pain Medication

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Douglas J Van Daele, University of Iowa
ClinicalTrials.gov Identifier:
NCT00583453
First received: December 20, 2007
Last updated: December 11, 2013
Last verified: December 2013

December 20, 2007
December 11, 2013
July 2007
December 2013   (final data collection date for primary outcome measure)
To compare analgesia in subjects receiving celecoxib versus placebo [ Time Frame: throughout 10 days post-operative ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00583453 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Celecoxib as a Post-tonsillectomy Pain Medication
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Tonsillitis
  • 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

  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
18
December 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00583453
200703765
No
Douglas J Van Daele, University of Iowa
University of Iowa
Pfizer
Principal Investigator: Douglas VanDaele, MD Department of Otolaryngology—Head & Neck Surgery
University of Iowa
December 2013

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