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

Phase 3

Completed

Brief 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

Detailed Description: To assess the safety of intravenous acetaminophen (IV APAP) when used over one or more days for the treatment of acute pain or fever in pediatric (neonates, infants, children and adolescents) inpatients who are unable to take anything by mouth (NPO), require or would benefit from IV treatment, or are willing and able to stay on IVAPAP therapy for 1 to 7 days.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
IV Acetaminophen	IV Acetaminophen	40 to 75 mg/kg/day every 4 to 6 hours

Primary Outcome Measures

Name	Time	Method
Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE)	First dose to end of treatment period	A TEAE is defined as an adverse event that starts on or after the start of study medication.
Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event	First dose to 30 days after last dose	A Serious Treatment Emergent Adverse Event is defined as any untoward medical occurrence at any dose of IV APAP that; * results in death * is life-threatening * requires inpatient hospitalization or causes prolongation of existing hospitalization * results in persistent or significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event

Secondary Outcome Measures

Name	Time	Method
Subject's (Parent/Guardian) Global Evaluation of Study Treatment	Day 0 to Day 5, Day 7 or Early Termination from study	Subject's (parent/guardian) was asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair, 2=good, 3= excellent).
Physician's Global Assessment of Study Treatment	End of study or Early Termination	Physicians were asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair,2=good, 3= excellent).

Locations (14): Johns Hopkins University
🇺🇸
Baltimore, Maryland, United States
SUNY Stony Brook
🇺🇸
Stony Brook, New York, United States
Baylor College of Medicine
🇺🇸
Houston, Texas, United States
University of Missouri
🇺🇸
Columbia, Missouri, United States
Hospital for Special Surgery
🇺🇸
New York, New York, United States
Lucile Salter Packard Children's Hospital at Stanford
🇺🇸
Stanford, California, United States
Alfred Dupont Hospital for Children
🇺🇸
Wilmington, Delaware, United States
University of Michigan Ann Arbor
🇺🇸
Ann Arbor, Michigan, United States
Oregon Health and Science University
🇺🇸
Portland, Oregon, United States
Children's Hospital of Philadelphia
🇺🇸
Philadelphia, Pennsylvania, United States
Houston Neonatal-Perinatal Physicians
🇺🇸
Bellaire, Texas, United States
University of Pittsburgh
🇺🇸
Pittsburgh, Pennsylvania, United States
Children's National Medical Center
🇺🇸
Washington, DC, District of Columbia, United States
Thomas Jefferson University
🇺🇸
Philadelphia, Pennsylvania, United States