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Management of Post-Tonsillectomy Pain in Pediatric Patients

Sponsor
Washington University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT04551196
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
14.1
Anticipated Duration (Months)
7.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Alternating Acetaminophen and Ibuprofen
  • Drug: Combined Acetaminophen and Ibuprofen
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Single-center, randomized, open-label, non-inferiority treatment pilot studySingle-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 :
Sep 28, 2020
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

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 Names:
  • 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 Names:
  • Combined regimen

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of FLACC pain scores ≥7 from POD 1 through POD 3 [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 [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 [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 [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 [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 [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 [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 [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 [up to 7 days following consent]

      Incidence of adverse events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Saint Louis Children's Hospital Saint Louis Missouri United States 63110

    Sponsors and Collaborators

    • Washington University School of Medicine

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT04551196
    Other Study ID Numbers:
    • 202002118
    First Posted:
    Sep 16, 2020
    Last Update Posted:
    Oct 5, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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:
    Tonsillitis
    Pain, Postoperative
    Hypertrophy
    Acetaminophen
    Ibuprofen

    Study Results

    No Results Posted as of Oct 5, 2021