Safety and Efficacy of Intravenous Acetaminophen (IV APAP) in Adult Inpatients
Condition: Acute Pain; Fever
MeSH terms: Acute Pain
Intervention: IV Acetaminophen
Intervention description: Arm 1: 1 g IV Acetaminophen every 6 hours administered for five days. Arm 2: 650 mg IV Acetaminophen every 4 hours administered for five days. Arm 3: The standard of care treatments were defined as any medication the investigator deemed appropriate to treat the subject, including products containing acetaminophen but excluding IV acetaminophen.
Intervention MeSH terms: Acetaminophen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 213.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Acute pain; Fever; IV Acetaminophen; Analgesic

Summary:

      The study will be investigating safety and efficacy administration of repeated dose of IV
      Acetaminophen (IV APAP) over five days for the treatment of acute pain or fever in adult
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent prior to participation in the Study

          -  Be at least 18 years of age and weigh at least 41 kilogram (kg)

          -  Be anticipated by the Investigator to require multi-day (target is five days) use of
             IV treatment either because of having a "nothing by mouth" (NPO) status having a
             medical condition that makes oral intake difficult having a medical condition that
             requires IV treatment

          -  Be willing to undergo 5 days of treatment with IV acetaminophen for the treatment of
             pain or fever (defined as a core temperature greater than or equal to 38 degrees
             celsius). Note that Subjects have a slightly less than 15% chance (one in seven) of
             being assigned to the Control Group and receiving standard of care treatment, but no
             IV APAP.

          -  Have the ability to read and understand the Study procedures and have the ability to
             communicate meaningfully with the Study Investigator and staff

          -  If a female of child bearing potential, have a negative pregnancy test within 48 hours
             of randomization

        Exclusion Criteria:

          -  Has a significant medical disease, laboratory abnormality or condition that, in the
             Investigator's judgment, could compromise the Subject's welfare or would otherwise
             contraindicate Study participation

          -  Is expected to have difficulty in communicating with the Study staff or completing
             Study requirements (including follow up visits)

          -  Has known hypersensitivity to acetaminophen or the inactive ingredients (excipients)
             of IV acetaminophen or any contraindication to receiving acetaminophen

          -  Has impaired liver function, e.g., Alanine aminotransferase (ALT) greater than or
             equal to 3 times the upper limit of normal (ULN), bilirubin greater than or equal to 3
             times ULN, known active hepatic disease (e.g., hepatitis), evidence of clinically
             significant chronic liver disease or other condition affecting the liver (e.g.,
             alcoholism as defined by DSM-IV, cirrhosis or chronic hepatitis)

          -  Has participated in an interventional clinical Study (investigational or marketed
             product) within 30 days of Study entry