Completed

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

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What is being tested

Celecoxib

+ Placebo

Drug
Who is being recruted

Agnosia+12

+ Infections

+ Stomatognathic Diseases

Over 18 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Placebo-ControlledPhase 2
Interventional
Study Start: October 2007
See protocol details

Summary

Principal SponsorUniversity of Iowa
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2007

Actual date on which the first participant was enrolled.

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.

Official TitlePerioperative Use of Celecoxib to Improve Pain Control in Patients Undergoing Tonsillectomy: a Randomized, Double Blind, Placebo-controlled Trial
NCT00583453
Principal SponsorUniversity of Iowa
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

18 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AgnosiaInfectionsStomatognathic DiseasesNervous System DiseasesNeurologic ManifestationsOtorhinolaryngologic DiseasesPerceptual DisordersPharyngeal DiseasesPharyngitisRespiratory Tract DiseasesRespiratory Tract InfectionsSigns and SymptomsPathological Conditions, Signs and SymptomsTonsillitisNeurobehavioral Manifestations

Criteria

3 inclusion criteria required to participate
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

11 exclusion criteria prevent from participating
History of bleeding disorders

History of liver or kidney dysfunction

History of allergy to sulfa containing medications

History of lactose intolerance

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Celecoxib 200 mg tablets

Group II

Placebo
Placebo with same dosing schedule as the active comparator arm

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Iowa Hospitals & Clinics

Iowa City, United StatesOpen University of Iowa Hospitals & Clinics in Google Maps
CompletedOne Study Center