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Postoperative Ibuprofen Use and Risk of Bleeding in Pediatric Tonsillectomy

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ClinicalTrials.gov Identifier: NCT03385057
Recruitment Status : Withdrawn (Study design flaws; research design needed to be reconfigured)
First Posted : December 28, 2017
Last Update Posted : September 20, 2018
Sponsor:
Collaborators:
Emory University
University Hospitals Cleveland Medical Center
Madigan Army Medical Center
United States Naval Medical Center, Portsmouth
Rady Children's Hospital, San Diego
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary

Brief Summary:
Pediatric tonsillectomy is one of the most common surgical procedures annually in the United States; risks include postoperative hemorrhage and poor pain control. Controversy exists regarding optimal pharmacologic pain management following surgery, as each drug's efficacy is balanced by its specific side effects. Ibuprofen is effective in controlling postoperative pain following tonsillectomy, but its mechanism of action results in decreased platelet function, which may increase postoperative bleeding events. This is a multicenter, randomized control non-inferiority trial designed to assess the relationship between short-course ibuprofen use and post-tonsillectomy bleeding when compared to acetaminophen.

Condition or disease Intervention/treatment Phase
Tonsillectomy With or Without Adenoidectomy Drug: Ibuprofen Drug: Acetaminophen Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Postoperative Ibuprofen Use and Risk of Bleeding in Pediatric Tonsillectomy
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Tonsillitis

Arm Intervention/treatment
Active Comparator: Ibuprofen Arm Drug: Ibuprofen
Grape-flavored ibuprofen 100mg/5mL (Leader®) will be dispensed. Ibuprofen will be dosed at 10mg/kg (max dose 600mg) QID (roughly Q6 hours, however we left dosing QID to allow for some flexibility in the dosing schedule to accommodate patient sleeping schedules). The pharmacy will manipulate the volume of each medication using Ora Blend suspension so that for each child, weight-based dosing of each medication will be equivalent in volume. The first dose of study medication will be dispensed 4 hours after the preoperative acetaminophen dose. Thereafter, medication will be dosed QID (or roughly 6 hours apart). Surgeons, nursing staff, and patients and their families will be blinded regarding the type of medication administered.
Other Name: Motrin

Active Comparator: Acetaminophen Drug: Acetaminophen
Grape-flavored acetaminophen 160mg/5mL (Leader®) will be dispensed based upon the arm to which each participant has been randomized. Acetaminophen at 15mg/kg (max dose 650mg), dosing will be QID (roughly Q6 hours, however we left dosing QID to allow for some flexibility in the dosing schedule to accommodate patient sleeping schedules). The pharmacy will manipulate the volume of each medication using Ora Blend suspension so that for each child, weight-based dosing of each medication will be equivalent in volume. The first dose of study medication will be dispensed 4 hours after the preoperative acetaminophen dose. Thereafter, medication will be dosed QID (or roughly 6 hours apart). Surgeons, nursing staff, and patients and their families will be blinded regarding the type of medication administered.
Other Name: Advil




Primary Outcome Measures :
  1. Post-tonsillectomy bleeding within 14 days of surgery. [ Time Frame: Within 14 days of surgery ]
    This will be classified by timing (<24 hours vs. 24 hours or more) and severity (level 1: bleeding by history alone; level 2: objective bleeding requiring hospital admission and observation; level 3: objective bleeding requiring operative intervention). Bleeding events will be documented during postoperative visit at two weeks as well as through medical record review.


Secondary Outcome Measures :
  1. Post-tonsillectomy pain control data through 14 days of surgery [ Time Frame: Through 14 days of surgery ]
    Post-tonsillectomy pain control data through 14 days of surgery. Patients and family members will receive validated pain control questionnaires to be filled out every day for the first 14 days following surgery (see Appendix ).



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients ages 2-18 undergoing tonsillectomy with or without adenoidectomy by electrocautery alone for all indications
  • Patients with complex medical conditions and craniofacial abnormalities will be included.
  • Family must understand and be able to read English.
  • Only patients who are not pregnant will be included.
  • Informed consent and, child assent (when appropriate) will be required for enrollment. Patients will provide signed and dated informed consent form.
  • Subjects will be willing and able to comply with all study procedures and be available for the duration of the study.

Exclusion Criteria:

  • Patients with a known personal or family history of a bleeding disorder.
  • Patients with a history of asthma, kidney or liver problems.
  • Patients with tonsillectomy or adenoidectomy performed using a cold knife technique, microdebrider, coblation or plasma knife.
  • Patients on NSAIDs for other medical conditions or those who have taken NSAIDs within 1 week of surgery
  • Patients with allergy to aspirin or other NSAIDs, acetaminophen, Red Dye #40 or Red Dye #33
  • Patients found to be pregnant will be excluded from participation. Pregnancy testing using urine beta-HCG will be performed on all children > 13 years of age, or those younger than 13 who are menstruating; this is the testing protocol used at the Children's Hospital of Boston.

Patients unwilling to enroll in the study will have the tonsillectomy with or without adenoidectomy performed according to current practice standards.


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): NCT03385057


Locations
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United States, California
Rady's Children's Hospital
San Diego, California, United States, 92123
United States, Georgia
Emory University and Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
United States, Ohio
Case Western University- Raimbow Babies and Children's
Cleveland, Ohio, United States, 44106
United States, Virginia
Portsmouth Naval Hospital
Portsmouth, Virginia, United States, 23708-2197
United States, Washington
Madigan Army Hospital
Tacoma, Washington, United States, 98431
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Emory University
University Hospitals Cleveland Medical Center
Madigan Army Medical Center
United States Naval Medical Center, Portsmouth
Rady Children's Hospital, San Diego
Investigators
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Principal Investigator: Christopher J Hartnick, MD Massachusetts Eye and Ear

Publications:

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Responsible Party: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT03385057     History of Changes
Other Study ID Numbers: 17-167H
First Posted: December 28, 2017    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ibuprofen
Hemorrhage
Pathologic Processes
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action