Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Celecoxib After Tonsillectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02934191
Recruitment Status : Completed
First Posted : October 14, 2016
Results First Posted : October 17, 2019
Last Update Posted : October 17, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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.

Condition or disease Intervention/treatment Phase
Tonsillectomy Drug: Celecoxib Other: Placebo Drug: Acetaminophen Drug: Oxycodone Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Celecoxib for Pain Management After Tonsillectomy
Study Start Date : June 2016
Actual Primary Completion Date : August 17, 2018
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Arm Intervention/treatment
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.
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

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.

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.
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.




Primary Outcome Measures :
  1. Difference in Number of Days Requiring Rescue Pain Medication [ Time Frame: 2 weeks post-operative ]
    The number of days on narcotic pain medication following surgery will be compared between the two treatment groups

  2. Difference in Amount of Rescue Pain Medication Consumed [ Time Frame: 2 weeks post-operative ]
    The total amount of rescue pain medication consumed in the 2-week postop period will be compared between the two treatment groups.


Secondary Outcome Measures :
  1. Difference in the Rate of Readmission For Complications [ Time Frame: 30 days post-operative ]
    The difference in the rate of readmission for dehydration or excessive pain will be compared between the two study groups.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02934191


Locations
Layout table for location information
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Pfizer
Investigators
Layout table for investigator information
Principal Investigator: John Germiller, MD, PhD Children's Hospital of Philadelphia
  Study Documents (Full-Text)

Documents provided by Children's Hospital of Philadelphia:

Layout table for additonal information
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02934191     History of Changes
Other Study ID Numbers: 15-011707
First Posted: October 14, 2016    Key Record Dates
Results First Posted: October 17, 2019
Last Update Posted: October 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Children's Hospital of Philadelphia:
Tonsillectomy
Post-operative complications
Post-operative pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Celecoxib
Acetaminophen
Oxycodone
Calcium Carbonate
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antacids
Gastrointestinal Agents