Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients
Condition: Pain; Fever
Intervention: IV Acetaminophen
Intervention description: Target is 1 to 7 days of therapy with intravenous (IV) Acetaminophen (IV APAP) at a dose of 40 to 75 mg/kg body weight/day administered as an IV infusion (or by syringe pump) over 15 minutes and given every 4 to 6 hours as a scheduled dose
Intervention MeSH terms: Acetaminophen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 37 Weeks
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      Intravenous acetaminophen (IVAPAP) is safe in repeated dose, multi-day clinical use when
      administered at a daily dose of 40 to 75 mg/kg body weight
    

Eligibility criteria:

        Inclusion Criteria:

          -  The Subject's Parent or Guardian must provide written informed consent, with Subject
             assent where appropriate, prior to the Subject's participation in the Study.

          -  Be less than 17 years of age and older than 37 weeks post conception

          -  Anticipated by the Investigator to require multi-day (minimum of one day) use of
             intravenous (IV) treatment either because of a having a status of nothing by mouth
             (NPO) or a medical condition that makes oral intake difficult or be willing to undergo
             at least 5 days of treatment with IV acetaminophen for the treatment of pain or fever

          -  Have the ability to read and understand the Study procedures and have the ability to
             communicate meaningfully with the Study Investigator and staff (if the Subject is of
             preverbal age or cannot read or communicate meaningfully, then the Subject's Parent or
             Guardian must meet this criterion)

          -  If a female of child bearing potential, have a negative pregnancy test

        Exclusion Criteria:

          -  Has significant medical disease(s), laboratory abnormalities or condition(s) that in
             the Investigator's judgment could compromise the Subject's welfare, ability to
             communicate with the Study staff, complete Study activities, or would otherwise
             contraindicate Study participation

          -  Has known hypersensitivity or contraindication to receiving IV acetaminophen or the
             inactive ingredients (excipients) of IV 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 the Diagnostic and Statistical Manual of Mental Disorders,
             Fourth Edition (DSM-IV), cirrhosis, or chronic hepatitis) that may suggest the
             potential for an increased susceptibility to hepatic toxicity with IV acetaminophen
             exposure

          -  Has participated in an interventional clinical Study (investigational or marketed
             product) within 30 days of Study entry