Clinical trial NCT00583453: Celecoxib as a Post-tonsillectomy Pain Medication
Official title: Perioperative Use of Celecoxib to Improve Pain Control in Patients Undergoing Tonsillectomy: a Randomized, Double Blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tonsillitis
Keywords: Tonsillectomy
Analgesia
Pain measurement
Celecoxib
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2007-12-31
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Self-reported Pain Score
timeFrame: day of procedure through post-operative day 10
Secondary outcomes:
measure: Self-reported Activity Level
timeFrame: From operative day through 10 days post-operative
measure: Acetaminophen Equivalent Use
timeFrame: From operative day through 10 days post-operative
measure: Incidence of Post-operative Hemorrhage
timeFrame: From operative day through 10 days post-operative
measure: Total Morphine Equivalent
timeFrame: From operative day through 10 days post-operative
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
Study officials:
affiliation: Department of Otolaryngology-Head & Neck Surgery
name: Douglas VanDaele, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.