Acetaminophen (APAP) +/- Oxycodone
- Registration Number
- NCT04122443
- Lead Sponsor
- Montefiore Medical Center
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 393
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acetaminophen Acetaminophen Acetaminophen alone Oxycodone/ acetaminophen Acetaminophen Oxycodone + acetaminophen Oxycodone/ acetaminophen Oxycodone Oxycodone + acetaminophen
- Primary Outcome Measures
Name Time Method Change in Pain Assessment 2 hours following treatment Stage 1 (Open label): No Outcome Measures assessed
Stage 2 (Double blinded): Change in Pain Assessment from baseline was determined using the Numeric Rating Scale (NRS) for evaluating pain. The rating was verbalized, and the subject was asked to estimate current pain intensity on an 11-point scale, where 0 indicated no pain at all and 10 indicated the worst imaginable pain. Positive mean changes in NRS scores were associated with increased pain relief.
- Secondary Outcome Measures
Name Time Method Sustained Pain Relief Up to 48 hours following medication administration Stage 1 (Open label): No Outcome Measures assessed
Stage 2 (Double blinded): Sustained pain relief was determined using a four-item ordinal scale. The rating was verbal and the subject was asked to describe their level of pain within two hours of medication administration and maintaining this level, without rescue medication, for 48 hours. The patients used the following descriptors: severe, moderate, mild, or none. For reporting responses of 'mild' and 'none' were aggregated into a single category and 'moderate' and severe' were aggregated into a separate category.Satisfaction With Medication 2 hours following treatment Stage 1 (Open label): No Outcome Measures assessed
Stage 2 (Double blinded): The number of participants demonstrating satisfaction with medication was determined by asking participants if the same medication regimen would be desired during a subsequent episode of pain. Possible responses included "Yes", "No" or "Unsure"Medication-related Adverse Events 2 hours following treatment Stage 1 (Open label): No Outcome Measures assessed
Stage 2 (Double blinded): The number of participants demonstrating medication-related adverse events was tabulated by treatment arm/group.Adequacy of Analgesia 2 hours following treatment Stage 1 (Open label): No Outcome Measures assessed
Stage 2 (Double blinded): Adequacy of analgesia was determined by querying the participants by asking a single question: "Did the medication provided control your pain?" Answer choices: Yes (it did); No (It did not); and Unsure. The number of participants responses were summarized by category.
Trial Locations
- Locations (1)
Montefiore Medical Center
🇺🇸Bronx, New York, United States