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Management of Post-Tonsillectomy Pain in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT04551196
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
Single-center, randomized, open-label, non-inferiority treatment pilot study to evaluate the effectiveness of a combined acetaminophen and ibuprofen regimen for treatment of post-operative tonsillectomy pain in the pediatric population. 100 children undergoing tonsillectomy will be randomized to receive either a combined acetaminophen and ibuprofen regimen dosed every 6 hours or an alternating regimen of acetaminophen and ibuprofen dosed every 3 hours.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Tonsillar Hypertrophy Tonsillitis Drug: Alternating Acetaminophen and Ibuprofen Drug: Combined Acetaminophen and Ibuprofen Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-center, randomized, open-label, non-inferiority treatment pilot study
Masking: None (Open Label)
Masking Description: Open-label
Primary Purpose: Treatment
Official Title: Effectiveness of a Combined Acetaminophen and Ibuprofen Regimen for Management of Post-Tonsillectomy Pain in Pediatric Patients
Actual Study Start Date : September 28, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Arm Intervention/treatment
Active Comparator: Alternating Regimen
A regimen of acetaminophen and ibuprofen alternating doses every 3 hours.
Drug: Alternating Acetaminophen and Ibuprofen
Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours.
Other Name: Alternating regimen

Active Comparator: Combined Regimen
A regimen of acetaminophen and ibuprofen dosed together every 6 hours.
Drug: Combined Acetaminophen and Ibuprofen
Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours.
Other Name: Combined regimen




Primary Outcome Measures :
  1. Proportion of FLACC pain scores ≥7 from POD 1 through POD 3 [ Time Frame: up to 3 days following consent ]

    The proportion of FLACC (Faces, Legs, Activity, Cry, and Consolability scale) pain scores ≥7 from POD 1 through POD 3 compared between the combined and the alternating medication regimens.

    The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2.



Secondary Outcome Measures :
  1. Proportion of FLACC pain scores ≥7 on each individual POD 1, 3, and 7 [ Time Frame: 3 separate individual days, will be completed days after the surgery ]

    The proportion of FLACC (Faces, Legs, Activity, Cry, and Consolability scale) pain scores ≥7 on each individual POD 1, 3, and 7 compared between the combined and the alternating medication regimens.

    The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2.


  2. Proportion of cumulative FLACC pain scores ≥7 from POD 1 through POD 7 [ Time Frame: up to 7 days following consent ]

    The proportion of cumulative FLACC pain scores ≥7 from POD 1 through POD 7 compared between the combined and the alternating medication regimens.

    The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2.


  3. Proportion of Faces pain scores ≥8 on POD 1, 3, and 7 [ Time Frame: 3 separate individual days, will be completed days after the surgery ]

    The proportion of Faces pain scores ≥8 on POD 1, 3, and 7 compared between the combined and the alternating medication regimens.

    The Faces scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.


  4. Proportion of cumulative Faces pain scores ≥8 from POD 1 through POD 7 [ Time Frame: up to 7 days following consent ]

    The proportion of cumulative Faces pain scores ≥8 from POD 1 through POD 7 compared between the combined and the alternating medication regimens.

    The Faces scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.


  5. Rescue Medication Usage through POD 3 [ Time Frame: up to 3 days following consent ]
    The proportion of rescue medication usage from POD 1 through POD 3 compared between the combined and the alternating medication regimens.

  6. Rescue Medication Usage through POD 7 [ Time Frame: up to 7 days following consent ]
    The proportion of rescue medication usage from POD 1 through POD 7 compared between the combined and the alternating medication regimens.

  7. Proportion of subjects that adhere to the assigned medication regimen [ Time Frame: up to 3 days following consent ]
    Proportion of subjects that adhere to the assigned medication regimen compared between the combined and the alternating medication regimens as determined by the medication log that the participants return at the end of the study.

  8. Adverse Events [ Time Frame: up to 7 days following consent ]
    Incidence of adverse events



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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 4 to 17 years of age at time of enrollment
  • Undergoing tonsillectomy with or without adenoidectomy
  • Able to provide informed consent from parent or legal guardian
  • Able to provide assent if subject is a minor of appropriate age

Exclusion Criteria:

  • Allergy to acetaminophen or ibuprofen
  • Inability for study participant to cooperate with pain assessments
  • Known pregnancy
  • Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

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): NCT04551196


Contacts
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Contact: Alan Hifko, MD 314-273-0783 Ahifko@wustl.edu
Contact: Micheal Montana, MD MontanaM@wustl.edu

Locations
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United States, Missouri
Saint Louis Children's Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Alan Hifko, MD    314-273-0783    Ahifko@wustl.edu   
Principal Investigator: Micheal Montana, MD         
Principal Investigator: David Leonard, MD         
Sponsors and Collaborators
Washington University School of Medicine
Publications:
National Prospective Tonsillectomy Audit Final Report. Royal College of Surgeons https://www.rcseng.ac.uk/library-and-publications/rcs-publications/docs/tonsillectomy-audit/
Ismail Zaidan & Amanda Lent. Post-Tonsillectomy Pain in Children: The Postcodeine Era. US Pharm. 41, 31-34 (2016).

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04551196    
Other Study ID Numbers: 202002118
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: October 2021
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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Tonsillitis
Pain, Postoperative
Hypertrophy
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Pathological Conditions, Anatomical
Pharyngitis
Respiratory Tract Infections
Infections
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Acetaminophen
Ibuprofen
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