Celecoxib After Tonsillectomy
Celecoxib for Pain Management After Tonsillectomy
1 other identifier
interventional
172
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 13, 2016
CompletedFirst Posted
Study publicly available on registry
October 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 17, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2019
CompletedResults Posted
Study results publicly available
October 17, 2019
CompletedMarch 10, 2020
March 1, 2020
2.2 years
October 13, 2016
September 24, 2019
March 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Difference in Number of Days Requiring Rescue Pain Medication
The number of days on narcotic pain medication following surgery will be compared between the two treatment groups
2 weeks post-operative
Difference in Amount of Rescue Pain Medication Consumed
The total amount of rescue pain medication consumed in the 2-week postop period will be compared between the two treatment groups.
2 weeks post-operative
Study Arms (2)
Acetaminophen/Oxycodone + Celecoxib
EXPERIMENTALSubjects will take acetaminophen orally (dose 15mg/kg/dose) in scheduled doses every 4 hours for the first 5 days. Subjects will also take celecoxib orally (dose is 6mg/kg twice a day with a maximum dose of 300mg twice a day). The first dose of celecoxib will be given preoperatively, within 1 hour prior to entering the operating room. The second dose will be given at bedtime on the night of surgery and subsequent doses will be given 12 hours apart. Supplemental standard of care oxycodone may be used to control breakthrough pain.
Acetaminophen/Oxycodone + Placebo
ACTIVE COMPARATORSubjects will take acetaminophen orally (dose 15mg/kg/dose) in scheduled doses every 4 hours for the first 5 days. Subjects will also take the placebo orally twice a day. The first dose of placebo will be given preoperatively, within 1 hour prior to entering the operating room. The second dose will be given at bedtime on the night of surgery and subsequent doses will be given 12 hours apart. Supplemental standard of care oxycodone may be used to control breakthrough pain.
Interventions
Dosing will be 6mg/kg twice a day with a maximum dose of 300mg twice a day. All ages will be given the suspension (concentration 100mg/5mL) orally
Placebo will have the same appearance, taste and consistency as celecoxib. Placebo will consist of calcium carbonate powder suspended in the same syrup as celecoxib. Dose of elemental calcium is 3 mg/kg/day.
Acetaminophen syrup at a dose of 15mg/kg/dose will be given every 4 hours for the first 5 days after surgery. After that point, is given as needed.
Oxycodone may be used every 4 hours post-operatively to treat breakthrough pain. The most commonly prescribed dose is 0.075mg/kg/dose (suspension) every 4 hours as needed.
Eligibility Criteria
You may qualify if:
- Males and females age 3 to 11 years inclusive.
- Scheduled to undergo tonsillectomy (with or without adenoidectomy).
- Weight ≥10 kg.
- 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.
- Parental/guardian permission (informed consent) and if appropriate, child assent.
You may not qualify if:
- Prior adenotonsillar surgery.
- Concomitant surgical procedure that adds more than mild additional pain. Note: ear tubes are always permissible.
- Coagulation disorder, or any other hematologic disorder that affects clotting or results in anemia.
- 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.
- Any degree of aspirin-sensitive asthma, or any history of asthma exacerbation caused by NSAID use.
- Severe obstructive sleep apnea, defined as an obstructive apnea-hypopnea index \>30 per hour and/or lowest oxygen saturation below 80%
- Significant chronic pulmonary disease, defined as subjects requiring oxygen therapy, ventilator support, or positive pressure therapy.
- Significant cardiac disease, defined as any one of the following: cardiovascular disease, structural cardiac anomalies, prior cardiac surgery, or requirement for cardiac anesthesia.
- Severely obese (weight or body mass index \> 95th percentile for age) or underweight (weight \<5th percentile for age).
- History of hepatic or renal disease, or condition that impairs hepatic or renal function.
- Juvenile rheumatoid arthritis (JRA).
- History of GI bleeding, or chronic GI condition that would increase risk of bleeding, ulceration, or perforation
- Hypertension.
- Craniofacial syndromes.
- Syndrome or neurologic condition that would hinder accurate assessment of postoperative pain.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital of Philadelphialead
- Pfizercollaborator
Study Sites (1)
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
Giordano T, Durkin A, Simi A, Shannon M, Dailey J, Facey H, Ballester L, Wetmore RF, Germiller JA. High-Dose Celecoxib for Pain After Pediatric Tonsillectomy: A Randomized Controlled Trial. Otolaryngol Head Neck Surg. 2023 Feb;168(2):218-226. doi: 10.1177/01945998221091695.
PMID: 35412873DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. John Germiller
- Organization
- Children's Hospital of Philadelphia
Study Officials
- PRINCIPAL INVESTIGATOR
John Germiller, MD, PhD
Children's Hospital of Philadelphia
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
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2016
First Posted
October 14, 2016
Study Start
June 1, 2016
Primary Completion
August 17, 2018
Study Completion
January 31, 2019
Last Updated
March 10, 2020
Results First Posted
October 17, 2019
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share