Multicenter Study to Compare Intravenous and Oral Acetaminophen for the Treatment of Acute Modera… (NCT02746263) | Clinical Trial Compass
TerminatedPhase 4
Multicenter Study to Compare Intravenous and Oral Acetaminophen for the Treatment of Acute Moderate to Severe Pain
Stopped: Business decision because enrollment was slower than expected
United States1 participantsStarted 2016-04-27
Plain-language summary
The purpose of this study is to compare intravenous (IV) and oral acetaminophen for the treatment of acute moderate to severe pain in combination with standard patient-controlled analgesia (PCA) in adult subjects following total knee replacement.
Who can participate
Age range50 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject must be adequately informed and understand the nature and risks of the study and must be able to provide a signature and date on the informed consent form.
✓. Subject must be male or females, between 50 and 90 years of age (inclusive) at Screening.
✓. Subject must have a weight range of 50 to 120 kg.
✓. Subject must be in a American Society of Anesthesiologists risk class of I, II, or III.
✓. Subject must have successfully completed an unilateral uncomplicated total knee replacement surgery, able to take oral medication, and report having moderate to severe acute pain as determined by a pain score ≥ 5 from the 11-point Numeric Pain Rating Scale (NPRS) scale during the period of 3 to 6 hours postsurgery.
✓. Female subjects of child-bearing potential must have a negative serum pregnancy test at the Screening and day-of-surgery.
✓. Subjects must be able to communicate effectively with study personnel.
✓. Subject must be able and willing to follow all protocol requirements, including operating a PCA device, and study restrictions.
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.
What they're measuring
1
Pain Intensity on a Numerical Pain Scale (NPS) for 18 Hours
. 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.