A Multi-Center Study of the Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of IV Acetaminophen for the Treatment of Acute Pain in Pediatric Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

197

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

August 31, 2015

Study Completion Date

November 30, 2015

Conditions
Acute Pain
Interventions
DRUG

IV Acetaminophen

IV Acetaminophen given every 6 hours (q6h); 4 doses, in 24 hours

DRUG

IV Control

IV Control q6h; 4 doses, in 24 hours

Trial Locations (22)

11203

Kings County Hospital Center, Brooklyn

15224

Children's Hospital of Pittsburgh, Pittsburgh

17033

Penn State Milton S. Hershey Medical Center, Hershey

19104

The Children's Hospital of Philadelphia, Philadelphia

23298

Virginia Commonwealth University, Richmond

27599

University of North Carolina-Chapel Hill, Chapel Hill

27710

Duke University, Durham

33236

Jackson Memorial Hospital, Miami

35294

Children's Of Alabama, Birmingham

37232

Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville

40202

University of Louisville, Louisville

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

Indiana University School of Medicine, Indianapolis

48109

Mott Children's Hospital, Ann Arbor

53226

Medical College of Wisconsin, Children's Hospital of Wisconsin, Milwaukee

55455

Amplatz Children's Hospital, Minneapolis

60611

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

75235

Children's Medical Center Dallas, Dallas

77030

Univ. of Texas Health Sciences Center, Houston

92123

Rady Children's Hosptial San Diego, San Diego

92868

Children's Hospital of Orange County, Orange

94305

Stanford University, Stanford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mallinckrodt

INDUSTRY