A Multi-Center Study of the Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of IV Acetaminophen for the Treatment of Acute Pain in Pediatric Patients
NCT ID: NCT01635101
Last Updated: 2020-01-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
197 participants
INTERVENTIONAL
2012-06-30
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Low Dose Acetaminophen
Participants receive a low dose of acetaminophen intravenously (IV) for 24 hours
IV Acetaminophen
IV Acetaminophen given every 6 hours (q6h); 4 doses, in 24 hours
High Dose Acetaminophen
Participants receive a low dose of acetaminophen (IV) for 24 hours
IV Acetaminophen
IV Acetaminophen given every 6 hours (q6h); 4 doses, in 24 hours
Placebo
Participants receive matching placebo (IV) for 24 hours
IV Control
IV Control q6h; 4 doses, in 24 hours
Interventions
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IV Acetaminophen
IV Acetaminophen given every 6 hours (q6h); 4 doses, in 24 hours
IV Control
IV Control q6h; 4 doses, in 24 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject will undergo surgery or had a traumatic injury expected to produce moderate to severe pain and patient is expected to require analgesic treatment for acute pain for 24 hours
* Subject has a medically reasonable need for IV treatment due to their underlying procedure(s) or medical condition(s) for the duration of the study
* Subject has reliable vascular access for administration of study medication and PK sampling
* Subject has a bodyweight which, in the opinion of the Investigator does not preclude participation in the study.
* Subject is free of other physical, mental, or medical conditions which, in the opinion of the Investigator, make study participation inadvisable or make it impossible to accurately assess efficacy or safety endpoints
* Subject's parent or guardian must provide written informed consent prior to participation in the study
* Subject's parent or guardian must have the ability to read and understand the study procedures and have the ability to communicate meaningfully with the study investigator and staff
Subject has not been administered any of the following:
* any acetaminophen-containing product, nonsteroidal anti-inflammatory agent, central alpha-adrenergic agents (e.g., clonidine, dexmedetomidine) or ketamine within 6 hours of baseline (T0)
* received a regional or neuraxial (caudal, epidural or spinal) anesthetic with local anesthetics within 6 hours of T0
* Subject does not have abnormal liver function tests from a sample obtained post-operatively/post-trauma and prior to randomization above protocol-specified limits
* Subject does not have significantly impaired renal function or known significant renal disease which in the opinion of the Investigator would contraindicate study participation.
* Subject had a nursing assessment documenting moderate to severe pain within 6 hours prior to randomization
* Subject required at least one dose of parenteral opioid medication for pain management (i.e., not pre-emptive therapy) during the 6-hour pre-randomization period, and is anticipated to require at least one dose of parenteral opioid medication during the 24 hour treatment period
* If subject is breast feeding, mother has not been administered any acetaminophen containing product in the previous 6 hours to T0 and throughout the treatment period
Exclusion Criteria
* Subject has known or suspected hypersensitivity to acetaminophen or the excipients of IV acetaminophen
* Subject has any significant medical condition that in the opinion of the Investigator contraindicates participation in the study or impairs the assessment of efficacy or safety
* Subject has participated in another interventional clinical study within 30 days of the planned study randomization date
1 Day
2 Years
ALL
No
Sponsors
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Mallinckrodt
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Team Leader
Role: STUDY_DIRECTOR
Mallinckrodt
Locations
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Children's Of Alabama
Birmingham, Alabama, United States
Children's Hospital of Orange County
Orange, California, United States
Rady Children's Hosptial San Diego
San Diego, California, United States
Stanford University
Stanford, California, United States
Jackson Memorial Hospital
Miami, Florida, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
University of Louisville
Louisville, Kentucky, United States
Mott Children's Hospital
Ann Arbor, Michigan, United States
Amplatz Children's Hospital
Minneapolis, Minnesota, United States
Kings County Hospital Center
Brooklyn, New York, United States
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Children's Medical Center Dallas
Dallas, Texas, United States
Univ. of Texas Health Sciences Center
Houston, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Medical College of Wisconsin, Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Hammer GB, Maxwell LG, Taicher BM, Visoiu M, Cooper DS, Szmuk P, Pheng LH, Gosselin NH, Lu J, Devarakonda K. Randomized Population Pharmacokinetic Analysis and Safety of Intravenous Acetaminophen for Acute Postoperative Pain in Neonates and Infants. J Clin Pharmacol. 2020 Jan;60(1):16-27. doi: 10.1002/jcph.1508. Epub 2019 Aug 25.
Other Identifiers
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CPI-APA-353
Identifier Type: -
Identifier Source: org_study_id
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