Celecoxib as a Post-tonsillectomy Pain Medication

February 12, 2017 updated by: Douglas J Van Daele, University of Iowa

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals & Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
day of procedure through post-operative day 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From operative day through 10 days post-operative
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.
From operative day through 10 days post-operative
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.
From operative day through 10 days post-operative
Total Morphine Equivalent
Time Frame: From operative day through 10 days post-operative
Participant reported mophine equivalent use
From operative day through 10 days post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Iowa

Collaborators

Pfizer

Investigators

  • Principal Investigator: Douglas VanDaele, MD, Department of Otolaryngology-Head & Neck Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

December 20, 2007

First Posted (Estimate)

December 31, 2007

Study Record Updates

Last Update Posted (Actual)

March 29, 2017

Last Update Submitted That Met QC Criteria

February 12, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200703765

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data will be uploaded through clinicaltrials.gov data tables

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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