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1. Males and females age 3 to 11 years inclusive.
2. Scheduled to undergo tonsillectomy (with or without adenoidectomy).
3. Weight ≥10 kg.
4. Girls ≥ 11 years of age must have a negative urine/serum pregnancy test on the day of surgery and must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.
5. Parental/guardian permission (informed consent) and if appropriate, child assent.
1. Prior adenotonsillar surgery.
2. Concomitant surgical procedure that adds more than mild additional pain. Note: ear
tubes are always permissible.
3. Coagulation disorder, or any other hematologic disorder that affects clotting or
results in anemia.
4. Moderate to severe asthma, defined as subjects who either (1) have daily symptoms
requiring daily use of short-acting bronchodilators, or (2) had an exacerbation in the
last 3 months requiring admission, emergency department (ED) visit, or systemic
corticosteroid administration.
5. Any degree of aspirin-sensitive asthma, or any history of asthma exacerbation caused
by NSAID use.
6. Severe obstructive sleep apnea, defined as an obstructive apnea-hypopnea index >30 per
hour and/or lowest oxygen saturation below 80%
7. Significant chronic pulmonary disease, defined as subjects requiring oxygen therapy,
ventilator support, or positive pressure therapy.
8. Significant cardiac disease, defined as any one of the following: cardiovascular
disease, structural cardiac anomalies, prior cardiac surgery, or requirement for
cardiac anesthesia.
9. Severely obese (weight or body mass index > 95th percentile for age) or underweight
(weight <5th percentile for age).
10. History of hepatic or renal disease, or condition that impairs hepatic or renal
function.
11. Juvenile rheumatoid arthritis (JRA).
12. History of GI bleeding, or chronic GI condition that would increase risk of bleeding,
ulceration, or perforation
13. Hypertension.
14. Craniofacial syndromes.
15. Syndrome or neurologic condition that would hinder accurate assessment of
postoperative pain.
16. Inability to feed orally or take oral pain medication.
17. Chronic pain disorders, or otherwise requiring pain medication more than once weekly.
18. Laboratory abnormalities on the preoperative complete blood count (CBC):
- Hemoglobin < 9 gm/dL
- Platelet count < 100,000/mm3
19. Any investigational drug use within 30 days prior to enrollment.
20. Pregnant or lactating females.
21. Parents/guardians or subjects who, in the opinion of the Investigator, may be
non-compliant with study schedules or procedures.
22. Hypersensitivity or allergic reactions to celecoxib, aspirin, or other NSAIDs,
including asthma flare ups
23. Allergy to sulfonamides or calcium carbonate.
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Descriptive Information | |||||||
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Brief Title ICMJE | Celecoxib After Tonsillectomy | ||||||
Official Title ICMJE | Celecoxib for Pain Management After Tonsillectomy | ||||||
Brief Summary | Tonsillectomy is one of the most common pediatric surgical procedures in the United States. Postoperative pain is substantial, with typical regimens employing narcotic derivatives and acetaminophen for 1-2 weeks after surgery. Recent enthusiasm for use of ibuprofen as an alternative has been tempered by equivocal data on its relative safety in regard to risk of postoperative hemorrhage. The primary objective is to evaluate efficacy of celecoxib for pain control after tonsillectomy in children. The secondary objective is to assess safety in regard to postoperative hemorrhage and adverse events. | ||||||
Detailed Description | This is a randomized, double-blind, placebo-controlled trial. Subjects will take acetaminophen plus either celecoxib or placebo in regular scheduled doses, and will supplement as needed with standard of care analgesic therapy (oxycodone/acetaminophen). Celecoxib is approved by the FDA for use in children ages 2 and older for treatment of juvenile rheumatoid arthritis (JRA). Celecoxib is on the Children's Hospital of Philadelphia (CHOP) formulary for use in (1) patients >= 2 years old for JRA, (2) patients >= 12 years old and >=40 kg who have increased risk for gastrointestinal (GI) adverse effects or bleeding concerns precluding use of traditional nonsteroidal anti-inflammatory drugs (NSAIDs), and (3) oncology patients with surface area >= 0.4 square meters for anti-angiogenesis. Celecoxib is approved by the FDA for use in adults for treatment of arthritic conditions, acute/ postoperative pain, and primary dysmenorrhea, and has been widely used since its introduction in 1998. Setting/Participants:Subjects are healthy children aged 3 to 11 years who undergo tonsillectomy with or without adenoidectomy at any Children's Hospital of Philadelphia (CHOP) location. Subjects with coagulation disorders are excluded. Approximately 300 subjects will be enrolled, 150 in each treatment group. Study Interventions and Measures: Subjects are provided celecoxib or placebo in scheduled doses every 12 hours for 5 days, then continue until they are pain-free, for a maximum of 10 days. Throughout the study, they are allowed to use oxycodone/acetaminophen as needed for additional pain control, following standard clinical care. Acetaminophen is used around the clock for the first 5 days in all subjects. For 14 days following surgery, subjects record pain levels on validated pain scale instruments, quantity of narcotic medication and acetaminophen required, and time to return to normal diet. All Emergency Department and hospital admissions during the 30 postoperative days are recorded, noting incidence of excess pain, dehydration, hemorrhage, and other complications. Pain control efficacy is assessed by comparing groups for number of days in which narcotic medication was used, and total quantity of rescue pain medication consumed. Rates of hospital readmission and postoperative hemorrhage, and the need for operative control, are also compared between groups. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||||
Condition ICMJE | Tonsillectomy | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 172 | ||||||
Original Estimated Enrollment ICMJE | 300 | ||||||
Actual Study Completion Date ICMJE | January 31, 2019 | ||||||
Actual Primary Completion Date | August 17, 2018 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 3 Years to 11 Years (Child) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02934191 | ||||||
Other Study ID Numbers ICMJE | 15-011707 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Children's Hospital of Philadelphia | ||||||
Study Sponsor ICMJE | Children's Hospital of Philadelphia | ||||||
Collaborators ICMJE | Pfizer | ||||||
Investigators ICMJE |
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PRS Account | Children's Hospital of Philadelphia | ||||||
Verification Date | March 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |