Clinical trial NCT00598702: Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Fever
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2008-01-22
Enrollment: 100
Sex: ALL
Minimum age (years): 37
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE)
timeFrame: First dose to end of treatment period
measure: Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event
timeFrame: First dose to 30 days after last dose
Secondary outcomes:
measure: Subject's (Parent/Guardian) Global Evaluation of Study Treatment
timeFrame: Day 0 to Day 5, Day 7 or Early Termination from study
measure: Physician's Global Assessment of Study Treatment
timeFrame: End of study or Early Termination
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Lucile Salter Packard Children's Hospital at Stanford
state: California
city: Wilmington
country: United States
facility: Alfred Dupont Hospital for Children
state: Delaware
city: Washington, DC
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Ann Arbor
state: Michigan
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Stony Brook
country: United States
facility: SUNY Stony Brook
state: New York
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Bellaire
country: United States
facility: Houston Neonatal-Perinatal Physicians
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References: