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Completed

NCT Number: NCT00598702

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

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Key information

Conditions

Pain Body Temperature Changes Fever Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

37 week–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Lucile Salter Packard Children's Hospital at Stanford, Stanford, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IV acetaminophen

Drug

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: IV APAP, APAP

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Mallinckrodt

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Jan 22, 2008
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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