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

Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00598702
• Other study ID #: CPI-APA-352
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2008
• Last updated: May 14, 2015
• Start date: January 2008
• Est. completion date: January 2009

Study information

• Verified date: May 2015
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 37 Weeks to 16 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fever
• Pain

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan Ann Arbor	Ann Arbor	Michigan
United States	Johns Hopkins University	Baltimore	Maryland
United States	Houston Neonatal-Perinatal Physicians	Bellaire	Texas
United States	University of Missouri	Columbia	Missouri
United States	Baylor College of Medicine	Houston	Texas
United States	Hospital for Special Surgery	New York	New York
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Lucile Salter Packard Children's Hospital at Stanford	Stanford	California
United States	SUNY Stony Brook	Stony Brook	New York
United States	Children's National Medical Center	Washington, DC	District of Columbia
United States	Alfred Dupont Hospital for Children	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	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	No
Secondary	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	No