Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00598702
Recruitment Status : Completed
First Posted : January 22, 2008
Results First Posted : January 6, 2011
Last Update Posted : May 10, 2017
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Pain Fever Drug: IV Acetaminophen Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Multi-Center, Open-Label, Prospective, Repeated Dose, Multi-Day Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients.
Study Start Date : January 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE) [ Time Frame: 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.

  2. Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event [ Time Frame: 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 :
  1. Subject's (Parent/Guardian) Global Evaluation of Study Treatment [ Time Frame: 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).

  2. Physician's Global Assessment of Study Treatment [ Time Frame: 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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   37 Weeks to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00598702

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

Layout table for additonal information
Responsible Party: Mallinckrodt Identifier: NCT00598702    
Other Study ID Numbers: CPI-APA-352
First Posted: January 22, 2008    Key Record Dates
Results First Posted: January 6, 2011
Last Update Posted: May 10, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs