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Pain Control Differences Between Oxycodone and Ibuprofen in Children With Isolated Forearm Injuries

Primary Purpose

Forearm Injuries, Pain, Acute, Pediatric ALL

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oxycodone
Ibuprofen
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Forearm Injuries focused on measuring oxycodone, ibuprofen

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 6 to 17 year old children presenting for care in the St. Louis Children's Hospital Emergency Department
  2. Suspected acute (within 24 hours) isolated forearm fracture at the time of initial Triage assessment
  3. American Society of Anesthesiologist physical status (ASA-PS) classification of I or II
  4. Child with parent or legal guardian.

Exclusion Criteria:

  1. Multiple injuries
  2. Known adverse reaction to either ibuprofen or oxycodone pts with abnormal bones or metabolic conditions that affect bones
  3. Administration of any opioid within 2 hours prior to presentation
  4. Non-English speaking
  5. Foster care, police custody, presenting without legal guardian

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Ibuprofen Group

    Oxycodone Group

    Arm Description

    To compare analgesia from ibuprofen to oxycodone in the initial treatment of acute pain in suspected isolated forearm fractures in children.

    To compare analgesia from ibuprofen to oxycodone in the initial treatment of acute pain in suspected isolated forearm fractures in children.

    Outcomes

    Primary Outcome Measures

    Pain reduction
    An appreciable decrease in pain scores (2 point reduction) from presentation to discharge

    Secondary Outcome Measures

    Full Information

    First Posted
    August 19, 2020
    Last Updated
    August 19, 2020
    Sponsor
    Washington University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04523623
    Brief Title
    Pain Control Differences Between Oxycodone and Ibuprofen in Children With Isolated Forearm Injuries
    Official Title
    Oxycodone or Ibuprofen for Suspected Isolated Forearm Fractures in Pediatric Patients: A Randomized Noninferiority Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2020 (Anticipated)
    Primary Completion Date
    February 2021 (Anticipated)
    Study Completion Date
    February 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Washington University School of Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    Children presenting to the Emergency Room with the chief complaint of forearm injury and/or pain will be randomized to receive oral Oxycodone or Ibuprofen to control pain.
    Detailed Description
    A randomized, blinded cohort study. Consented patients will be randomized to receive either ibuprofen or oxycodone after initial RN patient assessment in Emergency Department Triage determines a need for radiographs to evaluate for possible forearm fracture. Pain assessment scores will be determined at Triage and at 30-minute intervals throughout the patient's course until the patient is discharged home or additional analgesic medication is administered.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Forearm Injuries, Pain, Acute, Pediatric ALL
    Keywords
    oxycodone, ibuprofen

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ibuprofen Group
    Arm Type
    Experimental
    Arm Description
    To compare analgesia from ibuprofen to oxycodone in the initial treatment of acute pain in suspected isolated forearm fractures in children.
    Arm Title
    Oxycodone Group
    Arm Type
    Experimental
    Arm Description
    To compare analgesia from ibuprofen to oxycodone in the initial treatment of acute pain in suspected isolated forearm fractures in children.
    Intervention Type
    Drug
    Intervention Name(s)
    Oxycodone
    Intervention Description
    oxycodone 0.2mg/kg, max 10mg to be administered, randomized between that and Ibuprofen
    Intervention Type
    Drug
    Intervention Name(s)
    Ibuprofen
    Intervention Description
    ibuprofen 10mg/kg, max 800mg, randomized between that and Oxycodone
    Primary Outcome Measure Information:
    Title
    Pain reduction
    Description
    An appreciable decrease in pain scores (2 point reduction) from presentation to discharge
    Time Frame
    180 minutes total

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 6 to 17 year old children presenting for care in the St. Louis Children's Hospital Emergency Department Suspected acute (within 24 hours) isolated forearm fracture at the time of initial Triage assessment American Society of Anesthesiologist physical status (ASA-PS) classification of I or II Child with parent or legal guardian. Exclusion Criteria: Multiple injuries Known adverse reaction to either ibuprofen or oxycodone pts with abnormal bones or metabolic conditions that affect bones Administration of any opioid within 2 hours prior to presentation Non-English speaking Foster care, police custody, presenting without legal guardian
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    John E Graham
    Phone
    314-273-2734
    Email
    grahamje@wustl.edu

    12. IPD Sharing Statement

    Citations:
    Citation
    Ibuprofen or oxycodone? An observational cohort study of post emergency department discharge management of children's fracture pain. Ali S., Drendel A.L., Rosychuk R.J., Le May S., McGrath P., Carleton B., Johnson D.W. Canadian Journal of Emergency Medicine 2016 18 Supplement 1 (S47).
    Results Reference
    background
    PubMed Identifier
    18772726
    Citation
    Charney RL, Yan Y, Schootman M, Kennedy RM, Luhmann JD. Oxycodone versus codeine for triage pain in children with suspected forearm fracture: a randomized controlled trial. Pediatr Emerg Care. 2008 Sep;24(9):595-600. doi: 10.1097/PEC.0b013e3181850ca3.
    Results Reference
    background
    PubMed Identifier
    25358276
    Citation
    Kircher J, Drendel AL, Newton AS, Dulai S, Vandermeer B, Ali S. Pediatric musculoskeletal pain in the emergency department: a medical record review of practice variation. CJEM. 2014 Nov;16(6):449-57. doi: 10.1017/s1481803500003468.
    Results Reference
    background
    PubMed Identifier
    29114833
    Citation
    Chang AK, Bijur PE, Esses D, Barnaby DP, Baer J. Effect of a Single Dose of Oral Opioid and Nonopioid Analgesics on Acute Extremity Pain in the Emergency Department: A Randomized Clinical Trial. JAMA. 2017 Nov 7;318(17):1661-1667. doi: 10.1001/jama.2017.16190.
    Results Reference
    background
    PubMed Identifier
    30810754
    Citation
    Ilyas AM, Miller AJ, Graham JG, Matzon JL. A Prospective, Randomized, Double-Blinded Trial Comparing Acetaminophen, Ibuprofen, and Oxycodone for Pain Management After Hand Surgery. Orthopedics. 2019 Mar 1;42(2):110-115. doi: 10.3928/01477447-20190221-02. Epub 2019 Feb 27.
    Results Reference
    background
    PubMed Identifier
    25624387
    Citation
    Kelly LE, Sommer DD, Ramakrishna J, Hoffbauer S, Arbab-Tafti S, Reid D, Maclean J, Koren G. Morphine or Ibuprofen for post-tonsillectomy analgesia: a randomized trial. Pediatrics. 2015 Feb;135(2):307-13. doi: 10.1542/peds.2014-1906.
    Results Reference
    background
    PubMed Identifier
    24904812
    Citation
    Moradi M, Esmaeili S, Shoar S, Safari S. Use of oxycodone in pain management. Anesth Pain Med. 2012 Spring;1(4):262-4. doi: 10.5812/aapm.4529. Epub 2012 Apr 1.
    Results Reference
    background
    PubMed Identifier
    29107409
    Citation
    Tsze DS, von Baeyer CL, Pahalyants V, Dayan PS. Validity and Reliability of the Verbal Numerical Rating Scale for Children Aged 4 to 17 Years With Acute Pain. Ann Emerg Med. 2018 Jun;71(6):691-702.e3. doi: 10.1016/j.annemergmed.2017.09.009. Epub 2017 Nov 6.
    Results Reference
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    Pain Control Differences Between Oxycodone and Ibuprofen in Children With Isolated Forearm Injuries

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