Acetaminophen (APAP) +/- Oxycodone

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 4

Conditions: Musculoskeletal Pain

Treatments: Drug: Oxycodone; Drug: Acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT04122443

2019-10592

Details and patient eligibility

About

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

Enrollment: 393 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

393 participants in 2 patient groups

Acetaminophen

Active Comparator group

Description:

Acetaminophen alone

Treatment:

Drug: Acetaminophen

Oxycodone/ acetaminophen

Active Comparator group

Description:

Oxycodone + acetaminophen

Treatment:

Drug: Oxycodone

Drug: Acetaminophen