A Randomized Study of Ibuprofen + Oxycodone/Acetaminophen Versus Ibuprofen + Acetaminophen for ED Patients With Insufficient Relief of Acute Musculoskeletal Pain After Treatment With Prescription Strength Ibuprofen

2019-10592

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

2019-12-01

2022-07-31

2022-07-31

Completed

Early phase I

393

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 393, 'type': 'ACTUAL'}}

2024-02-28