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Celecoxib as a Post-tonsillectomy Pain Medication

This study has been completed.
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: February 12, 2017
Last verified: February 2017
  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
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

Resource links provided by NLM:


Further study details as provided by Douglas J Van Daele, University of Iowa:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.

  • 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.

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


Enrollment: 18
Study Start Date: October 2007
Study Completion Date: May 2016
Primary Completion Date: December 2013 (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 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


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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583453

Locations
United States, Iowa
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Pfizer
Investigators
Principal Investigator: Douglas VanDaele, MD Department of Otolaryngology—Head & Neck Surgery
  More Information

Publications:
Responsible Party: Douglas J Van Daele, Associate Professor of Otolaryngology—Head & Neck Surgery, University of Iowa
ClinicalTrials.gov Identifier: NCT00583453     History of Changes
Other Study ID Numbers: 200703765
Study First Received: December 20, 2007
Results First Received: February 12, 2017
Last Updated: February 12, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be uploaded through clinicaltrials.gov data tables

Keywords provided by Douglas J Van Daele, 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
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 18, 2017