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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Celecoxib 200 mg tablets |
|
| B | Placebo Comparator | Placebo with same dosing schedule as the active comparator arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | Celecoxib 200 mg capsule
1 capsule the night of surgery 1 capsule twice daily for 10 days immediately after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Activity Level | 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. | From operative day through 10 days post-operative |
| Acetaminophen Equivalent Use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas VanDaele, MD | Department of Otolaryngology-Head & Neck Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27357971 | Result | 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. |
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Data will be uploaded through clinicaltrials.gov data tables
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| ID | Title | Description |
|---|---|---|
| FG000 | Celecoxib as Experimerimental Intervention | Celecoxib 200 mg tablets Celecoxib: Celecoxib 200 mg capsule
1 capsule the night of surgery 1 capsule twice daily for 10 days immediately after the surgery |
| FG001 | Placebo Control, Active Comparator | Placebo with same dosing schedule as the active comparator arm Placebo: Placebo capsule
1 capsule the night of surgery 1 capsule twice daily for 10 days immediately after the surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Celecoxib 200 mg Tablets | Celecoxib 200 mg tablets Celecoxib: Celecoxib 200 mg capsule
1 capsule the night of surgery 1 capsule twice daily for 10 days immediately after the surgery |
| BG001 | Placebo With Same Dosing Schedule as the Active Comparator Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | pain score (units on a scale) | day of procedure through post-operative day 10 |
|
3 weeks postoperatively
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Celecoxib as Experimerimental Intervention | Celecoxib 200 mg tablets Celecoxib: Celecoxib 200 mg capsule
1 capsule the night of surgery 1 capsule twice daily for 10 days immediately after the surgery |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting, grade 1 | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment | A disorder characterized by the reflexive act of ejecting the contents of the stomach through the mouth. |
Small sample size Disproportionately female population
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Douglas Van Daele | University of Iowa | 319-353-8162 | douglas-van-daele@uiowa.edu |
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| ID | Term |
|---|---|
| D014069 | Tonsillitis |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
| Placebo | Drug | Placebo capsule
1 capsule the night of surgery 1 capsule twice daily for 10 days immediately after the surgery |
|
Participant reported acetaminophen use and its equivalent. Medication use was collected from reported participant journals. |
| From operative day through 10 days post-operative |
| Incidence of Post-operative Hemorrhage | 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. | From operative day through 10 days post-operative |
| Total Morphine Equivalent | Participant reported mophine equivalent use | From operative day through 10 days post-operative |
Placebo with same dosing schedule as the active comparator arm Placebo: Placebo capsule
1 capsule the night of surgery 1 capsule twice daily for 10 days immediately after the surgery |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Self-reported Activity Level | 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. | Posted | Mean | Standard Error | Activity score (units on a scale) | From operative day through 10 days post-operative |
|
|
|
|
| Secondary | Acetaminophen Equivalent Use | Participant reported acetaminophen use and its equivalent. Medication use was collected from reported participant journals. | Posted | Mean | Standard Error | mg | From operative day through 10 days post-operative |
|
|
|
|
| Secondary | Incidence of Post-operative Hemorrhage | 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. | Posted | Count of Participants | Participants | From operative day through 10 days post-operative |
|
|
|
| Secondary | Total Morphine Equivalent | Participant reported mophine equivalent use | Posted | Mean | Standard Error | mg | From operative day through 10 days post-operative |
|
|
|
|
| 0 |
| 9 |
| 1 |
| 9 |
| EG001 | Placebo Control, Active Comparator | Placebo with same dosing schedule as the active comparator arm Placebo: Placebo capsule
1 capsule the night of surgery 1 capsule twice daily for 10 days immediately after the surgery | 0 | 6 | 2 | 6 |
|
| Dehydration, grade 2 | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment | A disorder characterized by excessive loss of water from the body. It is usually caused by severe diarrhea, vomiting or lack of adequate fluid intake. Grade 2: I.V. fluids indicated for less than 24 hours |
|
| Dysphagia, grade 2 | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment | A disorder characterized by difficulty in swallowing. Grade 2 = symptomatic and altered eating / swallowing |
|
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| D009057 |
| Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Average, days 5 to 7 |
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| Average, days 8 to 10 |
|
| Average, days 5 to 7 |
|
| Average, days 8 to 10 |
|
| Average, days 5 to 7 |
|
| Average, days 8 to 10 |
|