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Purpose

This is an emergency department based randomized study of oxycodone/ acetaminophen versus acetaminophen alone for patients with acute musculoskeletal pain refractory to ibuprofen

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Acute musculoskeletal pain: Any pain attributable to muscles, bones, joints, tendons, ligaments or supporting structures, as determined by the clinical team, of 10 days duration or less. Prior to the onset of acute pain, patients cannot have experienced pain in the same body region during the prior six months - Pain has to be described as moderate or severe, when the patient is asked if the pain is mild, moderate or severe in intensity

Exclusion Criteria

  • Use of an non-steroidal anti-inflammatory drug within the previous six hours - Use of acetaminophen within the previous six hours - Use of an opioid within the previous ten days - Chronic pain, defined as any pain on >50% of days for at least 3 months prior to onset of acute pain - Gout

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Acetaminophen 		Acetaminophen alone
  • Drug: Acetaminophen
    Acetaminophen 650mg
Active Comparator
Oxycodone/ acetaminophen 		Oxycodone + acetaminophen
  • Drug: Acetaminophen
    Acetaminophen 650mg
  • Drug: Oxycodone
    Oxycodone 10mg

More Details

Status
Completed
Sponsor
Montefiore Medical Center

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.