Celecoxib After Tonsillectomy

NCT02934191

Last updated date
Study Location
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tonsillectomy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
3-11 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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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Advanced Information
Descriptive Information
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
  • Drug: Celecoxib
    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
    Other Name: Celebrex
  • Other: Placebo
    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.
    Other Name: Calcium carbonate placebo
  • Drug: Acetaminophen
    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.
  • Drug: Oxycodone
    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.
Study Arms  ICMJE
  • Experimental: Acetaminophen/Oxycodone + Celecoxib
    Subjects 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.
    Interventions:
    • Drug: Celecoxib
    • Drug: Acetaminophen
    • Drug: Oxycodone
  • Active Comparator: Acetaminophen/Oxycodone + Placebo
    Subjects 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:
    • Other: Placebo
    • Drug: Acetaminophen
    • Drug: Oxycodone
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
 (submitted: September 18, 2018)
172
Original Estimated Enrollment  ICMJE
 (submitted: October 13, 2016)
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:

  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.

Exclusion Criteria:

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Children's Hospital of Philadelphia
Study Sponsor  ICMJE Children's Hospital of Philadelphia
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:John Germiller, MD, PhDChildren's Hospital of Philadelphia
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