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OpenTrials
Completed

NCT Number: NCT00583453

Celecoxib as a Post-tonsillectomy Pain Medication

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celecoxib

Drug

Celecoxib 200 mg capsule

  • capsule the night before surgery
  • 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

Drug

Placebo capsule

  • capsule the night before surgery
  • capsules the morning of surgery

1 capsule the night of surgery

1 capsule twice daily for 10 days immediately after the surgery

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Collaborators

  • Pfizer

Registry information

Official study title

Perioperative Use of Celecoxib to Improve Pain Control in Patients Undergoing Tonsillectomy: a Randomized, Double Blind, Placebo-controlled Trial

Important dates

Study start
2007
Primary completion
2013
Study completion
2016
First posted
Dec 31, 2007
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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