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Ibuprofen Versus Acetaminophen vs Their Combination in the Relief of Musculoskeletal Pain in the Emergency Setting

Primary Purpose

Pain

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ibuprofen
Acetaminophen
Ibuprofen-acetaminophen combination
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring musculoskeletal pain, acetaminophen, ibuprofen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients who presented to the emergency department with pain (a verbal numeric pain score greater than 0 on a scale of 0 to 10 from none to greatest) secondary to an acute musculoskeletal injury of less than 24 hours of duration when one of the study investigators was present were eligible for enrollment

Exclusion Criteria:

  • Patients who had taken an opioid containing analgesic as well as those with a prior history of allergy or contraindications to ibuprofen or acetaminophen.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Experimental

    Arm Label

    Ibuprofen

    Acetaminophen

    Ibuprofen-acetaminophen combination

    Arm Description

    Ibuprofen 800 mg

    Acetaminophen 1 gm

    Ibuprofen 800 mg plus acetaminophen 1 gm

    Outcomes

    Primary Outcome Measures

    Pain Severity
    Pain score on 100 mm VAS from 0 (no pain) to 100 (worst pain)

    Secondary Outcome Measures

    Need for Rescue Pain Relief
    The need for additional analgesics

    Full Information

    First Posted
    April 4, 2013
    Last Updated
    December 29, 2014
    Sponsor
    Stony Brook University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01827475
    Brief Title
    Ibuprofen Versus Acetaminophen vs Their Combination in the Relief of Musculoskeletal Pain in the Emergency Setting
    Official Title
    Ibuprofen Versus Acetaminophen vs Their Combination in the Relief of Musculoskeletal Pain in the Emergency Setting
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2010 (undefined)
    Primary Completion Date
    July 2011 (Actual)
    Study Completion Date
    July 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stony Brook University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether the combination of ibuprofen and acetaminophen, is more effective than either single agent alone in treating pain from acute musculoskeletal injuries in the emergency department.
    Detailed Description
    The purpose of this study is to determine whether the combination of ibuprofen and acetaminophen, is more effective than either single agent alone in treating pain from acute musculoskeletal injuries in the emergency department. We hypothesize that the combination will be more effective than either agent alone in patients presenting to the emergency department with acute pain from musculoskeletal injuries such as sprain, and bruises. While each agent alone is effective to some degree, many patients do not find complete relief with them and often narcotic agents (with all of their potential side effects) are added. In this study patients experiencing any pain will be randomly given either ibuprofen OR acetaminophen OR their combination and their degree of pain severity will be measured every 15 minutes up to one hour. At the end of this 1 hour patients still experiencing pain and requiring additional pain relief will receive additional analgesics at the discretion of their treating physician. We will not only measure how much the pain severity was reduced but also the percentage of patients that require some form of additional or "rescue" medication.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain
    Keywords
    musculoskeletal pain, acetaminophen, ibuprofen

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ibuprofen
    Arm Type
    Active Comparator
    Arm Description
    Ibuprofen 800 mg
    Arm Title
    Acetaminophen
    Arm Type
    Active Comparator
    Arm Description
    Acetaminophen 1 gm
    Arm Title
    Ibuprofen-acetaminophen combination
    Arm Type
    Experimental
    Arm Description
    Ibuprofen 800 mg plus acetaminophen 1 gm
    Intervention Type
    Drug
    Intervention Name(s)
    Ibuprofen
    Other Intervention Name(s)
    motrin
    Intervention Description
    single dose
    Intervention Type
    Drug
    Intervention Name(s)
    Acetaminophen
    Other Intervention Name(s)
    tylenol
    Intervention Description
    single dose
    Intervention Type
    Drug
    Intervention Name(s)
    Ibuprofen-acetaminophen combination
    Other Intervention Name(s)
    motrin, tylenol
    Intervention Description
    single dose
    Primary Outcome Measure Information:
    Title
    Pain Severity
    Description
    Pain score on 100 mm VAS from 0 (no pain) to 100 (worst pain)
    Time Frame
    1 hour
    Secondary Outcome Measure Information:
    Title
    Need for Rescue Pain Relief
    Description
    The need for additional analgesics
    Time Frame
    1 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients who presented to the emergency department with pain (a verbal numeric pain score greater than 0 on a scale of 0 to 10 from none to greatest) secondary to an acute musculoskeletal injury of less than 24 hours of duration when one of the study investigators was present were eligible for enrollment Exclusion Criteria: Patients who had taken an opioid containing analgesic as well as those with a prior history of allergy or contraindications to ibuprofen or acetaminophen.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Adam J Singer, MD
    Organizational Affiliation
    Stony Brook University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32797734
    Citation
    Jones P, Lamdin R, Dalziel SR. Oral non-steroidal anti-inflammatory drugs versus other oral analgesic agents for acute soft tissue injury. Cochrane Database Syst Rev. 2020 Aug 12;8(8):CD007789. doi: 10.1002/14651858.CD007789.pub3.
    Results Reference
    derived

    Learn more about this trial

    Ibuprofen Versus Acetaminophen vs Their Combination in the Relief of Musculoskeletal Pain in the Emergency Setting

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