Status:

COMPLETED

Acetaminophen (APAP) +/- Oxycodone

Lead Sponsor:

Montefiore Medical Center

Conditions:

Musculoskeletal Pain

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 1 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 31 2022

Estimated Enrollment :

393 Patients enrolled

Trial Details

Trial ID

NCT04122443

Start Date

December 1 2019

End Date

July 31 2022

Last Update

February 28 2024

Active Locations (1)

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Montefiore Medical Center

The Bronx, New York, United States, 10467