Safety and Pharmacokinetic (PK) Study of Intravenous (IV) Acetaminophen Administration in Pediatric Inpatients

Phase 1

Completed

Brief Summary: We are doing this study to find out what happens to acetaminophen in the body after it is given to children through the vein. Children's bodies may handle drugs differently than adults. Understanding how long the drug stays in the body and how the drug is changed or metabolized by the body (called pharmacokinetics) is an important step in learning what the best dose of acetaminophen for children should be. We are also interested in learning about the safety of this medication when given to children.

Detailed Description: A Prospective, Multi-Center, Randomized, Open-Label, Single and Repeated Dose, 48 Hour Study, of Intravenous Acetaminophen in Pediatric Inpatients to Determine Pharmacokinetics (PK) and Safety in Acute Pain and Fever

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Intravenous (IV) Acetaminophen 15 milligrams/kilogram (mg/kg)	IV Acetaminophen	Intravenous Acetaminophen administered 15 milligrams/kilogram (mg/kg) every 8 hours (q8h) or every 6 hours (q6h) based age of subject
Intravenous (IV) Acetaminophen 12.5 (mg/kg)	IV Acetaminophen	Intravenous Acetaminophen administered 12.5 milligrams/kilogram (mg/kg) every 6 hours (q6h) or every 4 hours (q4h)

Primary Outcome Measures

Name	Time	Method
Single-dose Maximum Plasma Concentration (Cmax) , Micrograms Per Milliliter (µg/mL) Pharmacokinetics of IV Acetaminophen	Time Zero (just prior to first dose) to 24 hours post first dose	Cmax: Maximum Plasma Concentration
Single-dose Time to Reach Maximum Plasma Concentration [Tmax(h)] Pharmacokinetics of IV Acetaminophen	Time Zero (just prior to first dose) to 24 hours post first dose	Tmax: Time to reach maximum plasma concentration (Cmax)
Multiple-dose Terminal Elimination Half-life [t1/2(h)] Pharmacokinetics of IV Acetaminophen	48hrs	t1/2: Terminal elimination half-life
Multiple-dose Area Und the Curve (AUC) From Time 0 (Predose) to the Time of the Dosing Interval at Steady-state (0-t (µg*h/ml) Pharmacokinetics of IV Acetaminophen	Time Zero (just prior to first dose) to 48 hours post first dose	AUC 0-t (µg\*h/ml): Area under the plasma concentration versus time curve from time 0 (predose) to the time of the dosing interval at steady-state.

Secondary Outcome Measures

Name	Time	Method
Subjects Who Experience at Least One Serious Treatment-Emergent Adverse Event (TEAE)	First dose to 30 days following last dose of study medication	A Serious Treatment Emergent Adverse Event is defined as any untoward medical occurrence at any dose of IV acetaminophen 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
Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE)	First dose of study medication to 30 days after the last dose of study medication	A TEAE is defined as an adverse event that starts on or after the start of study medication

Locations (5): CS Mott Childrens Hospital
🇺🇸
Ann Arbor, Michigan, United States
Lucile Packard Children's Hospital
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Stanford, California, United States
Duke University Health Systems
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Durham, North Carolina, United States
Children's Hospital Of Philadelphia
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Philadelphia, Pennsylvania, United States
Children's Hospital Of Pittsburgh
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Pittsburgh, Pennsylvania, United States