Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients

Completed · Phase 3

Conditions studied: Pain, Fever

In brief

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

Key facts

Study ID

NCT00598702

Run by

Mallinckrodt

People needed

100

Starts

2008-01-01

Expected to finish

2009-01-01

Last updated by the study team

2017-05-10

Who can join

Age: 1 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Lucile Salter Packard Children's Hospital at Stanford — Stanford, California, United States
• Alfred Dupont Hospital for Children — Wilmington, Delaware, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• University of Michigan Ann Arbor — Ann Arbor, Michigan, United States
• University of Missouri — Columbia, Missouri, United States
• Hospital for Special Surgery — New York, New York, United States
• SUNY Stony Brook — Stony Brook, New York, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Houston Neonatal-Perinatal Physicians — Bellaire, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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