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

A Phase III Multi-Center, Open-Label, Prospective, Repeated Dose, Multi-Day Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients.

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

Study Overview

• Status: Completed
• Conditions: Pain; Fever
• Intervention / Treatment: Drug: IV Acetaminophen

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Lucile Salter Packard Children's Hospital at Stanford
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • Alfred Dupont Hospital for Children
  • District of Columbia
    • Washington, DC, District of Columbia, United States, 20010
      • Children's National Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Ann Arbor
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery
    • Stony Brook, New York, United States, 11794
      • SUNY Stony Brook
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh
  • Texas
    • Bellaire, Texas, United States, 77401
      • Houston Neonatal-Perinatal Physicians
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IV Acetaminophen; 40 to 75 mg/kg/day every 4 to 6 hours	Drug: IV Acetaminophen; 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; Other Names: APAP; IV APAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	First dose to 30 days after last dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	End of study or Early Termination

Collaborators and Investigators

• Sponsor: Mallinckrodt

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: January 9, 2008
• First Submitted That Met QC Criteria: January 16, 2008
• First Posted (Estimate): January 22, 2008

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: CPI-APA-352