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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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
Lucile Salter Packard Children's Hospital at Stanford
Stanford, California, United States
Alfred Dupont Hospital for Children
Wilmington, Delaware, United States
Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE)
A TEAE is defined as an adverse event that starts on or after the start of study medication.
Time frame: First dose to end of treatment period
Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event
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
Time frame: First dose to 30 days after last dose
Subject's (Parent/Guardian) Global Evaluation of Study Treatment
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).
Time frame: Day 0 to Day 5, Day 7 or Early Termination from study
Physician's Global Assessment of Study Treatment
Physicians were asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair,2=good, 3= excellent).
Time frame: End of study or Early Termination
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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
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Stony Brook, New York, United States
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Portland, Oregon, United States
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...and 4 more locations