Multicenter Study to Compare Intravenous and Oral Acetaminophen for the Treatment of Acute Moderate to Severe Pain

Exclusion criteria

• . Subject is from a vulnerable population, as defined by the Code of Federal Regulations Title 45, Part 46, 1. Section 46.111(b), including but not limited to employees (temporary, part-time, full time, etc.) or a family member of the research staff conducting the study, or of the sponsor, or of the clinical research organization, or of the Institutional Review Board.
• . Subject has an oxygen saturation of less than 95% while awake on room air.
• . Subject has a positive test result for human immunodeficiency virus, hepatitis B (surface antigen), or hepatitis C virus antibody at Screening.
• . Subject has used an average of 30 mg oral morphine equivalents or greater, 1 to 2 weeks prior to the day of surgery. Subjects who, in the investigator's opinion are developing opioid tolerance will be excluded.
• . Subject has a history of any drug allergy, hypersensitivity, or intolerance to acetaminophen or morphine or to any of the excipients in the IV or oral formulations used.
• . Subject has intra- or postoperative complications, which in the view of the investigator, makes the subject unsuitable for the participation of the study.
• . Subject has received neuraxial (spinal or epidural) opioid injected perioperatively.
• . Subject has received a local anesthetic, regional, or wound injection or continuous infusion by any route.