Perioperative Use of Celecoxib to Improve Pain Control in Patients Undergoing Tonsillectomy: a Randomized, Double Blind, Placebo-controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Iowa
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Self-reported Pain Score
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
B
Placebo with same dosing schedule as the active comparator arm
Intervention: Placebo (Drug)
A
Celecoxib 200 mg tablets
Intervention: Celecoxib (Drug)
Outcomes
Primary Outcomes
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
- Incidence of Post-operative Hemorrhage(From operative day through 10 days post-operative)
- Total Morphine Equivalent(From operative day through 10 days post-operative)
- Self-reported Activity Level(From operative day through 10 days post-operative)
- Acetaminophen Equivalent Use(From operative day through 10 days post-operative)
Investigators
Douglas J Van Daele
Associate Professor of Otolaryngology-Head & Neck Surgery
University of Iowa