A Multi-Center Study of the Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of IV Acetaminophen for the Treatment of Acute Pain in Pediatric Patients
A Randomized, Placebo Controlled, Multi-Center Study of the Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of IV Acetaminophen for the Treatment of Acute Pain in Pediatric Patients
1 other identifier
interventional
197
1 country
22
Brief Summary
The purpose of this study is to demonstrate the efficacy and safety of Intravenous (IV) acetaminophen plus rescue opioids for the relief of moderate to severe acute pain in neonates and infants (age \< 2 years) compared to placebo plus standard of care rescue opioids as well as characterize the concentration-effect relationship (PK/PD) of the intravenous acetaminophen as compared to the control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2012
Typical duration for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 29, 2012
CompletedFirst Posted
Study publicly available on registry
July 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedResults Posted
Study results publicly available
January 21, 2020
CompletedJanuary 21, 2020
May 1, 2017
3.2 years
June 29, 2012
September 10, 2019
January 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Rescue Opioid Consumption
Total micrograms per kilogram (µg/kg) of rescue opioid used during the same 24 hours the subject is on study medication
in 24 hours
Secondary Outcomes (5)
Time to First Rescue Medication
within 24 hours
Summary of Pain Intensity Using the Leuven Neonatal Pain Scale (LNPS) in Neonates
within 24 Hours
Summary of Pain Intensity Using the LNPS in Younger Infants
within 24 hours
Pain Intensity Using the FLACC Score in Intermediate Aged Infants
within 24 hours
Pain Intensity Using the FLACC Score in Older Infants
within 24 hours
Study Arms (3)
Low Dose Acetaminophen
EXPERIMENTALParticipants receive a low dose of acetaminophen intravenously (IV) for 24 hours
High Dose Acetaminophen
EXPERIMENTALParticipants receive a low dose of acetaminophen (IV) for 24 hours
Placebo
PLACEBO COMPARATORParticipants receive matching placebo (IV) for 24 hours
Interventions
IV Acetaminophen given every 6 hours (q6h); 4 doses, in 24 hours
Eligibility Criteria
You may qualify if:
- Subject is ≥ 28 weeks gestational age and \< 2 years old at study enrollment
- 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
You may not qualify if:
- Subject is not able to comply with the sampling requirements of the study
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mallinckrodtlead
Study Sites (22)
Children's Of Alabama
Birmingham, Alabama, 35294, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Rady Children's Hosptial San Diego
San Diego, California, 92123, United States
Stanford University
Stanford, California, 94305, United States
Jackson Memorial Hospital
Miami, Florida, 33236, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Amplatz Children's Hospital
Minneapolis, Minnesota, 55455, United States
Kings County Hospital Center
Brooklyn, New York, 11203, United States
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University
Durham, North Carolina, 27710, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232, United States
Children's Medical Center Dallas
Dallas, Texas, 75235, United States
Univ. of Texas Health Sciences Center
Houston, Texas, 77030, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Medical College of Wisconsin, Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
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.
PMID: 31448420DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Information Call Center
- Organization
- Mallinckrodt
Study Officials
- STUDY DIRECTOR
Clinical Team Leader
Mallinckrodt
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2012
First Posted
July 6, 2012
Study Start
June 1, 2012
Primary Completion
August 1, 2015
Study Completion
November 1, 2015
Last Updated
January 21, 2020
Results First Posted
January 21, 2020
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share