Phase 4
N=393
Acetaminophen (APAP) +/- Oxycodone
Musculoskeletal Pain
Bottom Line
View on ClinicalTrials.gov: NCT04122443 ↗Enrolled (actual)
393
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Change in Pain Assessment — 2.9; 4.0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Acetaminophen (Drug); Oxycodone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Assessment |
2.9; 4.0 | — |
| SECONDARY Sustained Pain Relief |
33; 43; 44; 34 | — |
| SECONDARY Adequacy of Analgesia |
51; 59; 23; 17; 0; 0 | — |
| SECONDARY Satisfaction With Medication |
41; 47; 22; 18; 10; 11 | — |
| SECONDARY Medication-related Adverse Events |
7; 26 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT04122443). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.