Celecoxib as a Post-tonsillectomy Pain Medication

NCT00583453 | Completed Phase 2 Results

• 1 other identifier: 200703765
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Tonsillitis

Keywords

Tonsillectomy; Analgesia; Pain measurement; Celecoxib

Outcome Measures

Primary Outcomes (1)

• Self-reported Pain Score

  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 Outcomes (4)

• Self-reported Activity Level

  From operative day through 10 days post-operative

• Acetaminophen Equivalent Use

  From operative day through 10 days post-operative

• Incidence of Post-operative Hemorrhage

  From operative day through 10 days post-operative

• Total Morphine Equivalent

  From operative day through 10 days post-operative

Study Arms (2)

A

ACTIVE COMPARATOR

Celecoxib 200 mg tablets

Drug: Celecoxib

B

PLACEBO COMPARATOR

Placebo with same dosing schedule as the active comparator arm

Drug: Placebo

Interventions

Celecoxib DRUG

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

Also known as: Celebrex

A

Placebo DRUG

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

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Iowa: lead
• Pfizer: collaborator

Study Sites (1)

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

• 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.

  PMID: 27357971 RESULT

MeSH Terms

Conditions

Tonsillitis; Agnosia

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Small sample size Disproportionately female population

Results Point of Contact

• Title: Douglas Van Daele
• Organization: University of Iowa

douglas-van-daele@uiowa.edu

319-353-8162

Study Officials

• Douglas VanDaele, MD

  Department of Otolaryngology-Head & Neck Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Otolaryngology-Head & Neck Surgery

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 31, 2007
• Study Start: October 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: May 1, 2016
• Last Updated: March 29, 2017
• Results First Posted: March 29, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)