Surgical Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen
A Multi-Center, Open-Label, Surgical Surveillance Trial To Evaluate The Safety And Efficacy Of A Shortened Infusion Time of Intravenous Ibuprofen
1 other identifier
interventional
300
1 country
22
Brief Summary
The primary objective of this study is to determine the safety of a single dose of intravenous ibuprofen administered over 5-10 minutes for the preemptive treatment of postoperative pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 pain
Started Jun 2011
Typical duration for phase_4 pain
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
First Submitted
Initial submission to the registry
April 12, 2011
CompletedFirst Posted
Study publicly available on registry
April 13, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedResults Posted
Study results publicly available
June 23, 2014
CompletedFebruary 28, 2024
February 1, 2024
1.5 years
April 12, 2011
April 15, 2014
February 5, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.
The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen
6 hours
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.
The incidence of treatment-emergent adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen
6 hours
Secondary Outcomes (3)
To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.
6 hours
To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.
6 hours
To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.
6 hours
Study Arms (1)
Intravenous ibuprofen
EXPERIMENTALIntravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.
Interventions
800 mg intravenous ibuprofen administered intravenously over 5-10 minutes
Eligibility Criteria
You may qualify if:
- Patients scheduled for surgery with anticipated need for postoperative analgesia
You may not qualify if:
- Patients with inadequate IV access
- Patients \<18 years of age
- History or allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin (or aspirin related products) or non-steroidal anti-inflammatory drug (NSAIDs)
- Active hemorrhage or clinically significant bleeding
- Pregnant or nursing
- Patients in the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery
- Inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board \[IRB\]), and agree to abide by the study restrictions
- Refusal to provide written authorization for use and disclosure of protected health information
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
UC San Diego Regional Center
La Jolla, California, 92037, United States
Neurovations (Queen of the Valley Hospital)
Napa, California, 94558, United States
University of Miami Health System
Miami, Florida, 33136, United States
Sheridan Clinical Research
Plantation, Florida, 33324, United States
RUSH Univ. Medical Center
Chicago, Illinois, 60612, United States
Univ. of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121-2483, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Detroit Medical Center
Detroit, Michigan, 48201, United States
North Mississippi Sports Medicine & Orthopaedic Clinic
Tupelo, Mississippi, 38801, United States
Albany Medical Center
Albany, New York, 12208, United States
State of New York Downstate Medical Center (SUNY)
Brooklyn, New York, 11203, United States
North Shore - Long Island Jewish Health System
Manhasset, New York, 11030, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University Health System
Durham, North Carolina, 27710, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Ohio State University Medical Center
Columbus, Ohio, 43201, United States
Penn State College of Medicine
Hershey, Pennsylvania, 17033, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Hendersonville Hospital/Comprehensive Pain Specialists
Hendersonville, Tennessee, 37075, United States
Parkland Memorial
Dallas, Texas, 75235, United States
Related Publications (1)
Gan TJ, Candiotti K, Turan A, Buvanendran A, Philip BK, Viscusi ER, Soghomonyan S, Bergese SD; Intravenous Ibuprofen Surgical Surveillance Trial Investigational Sites. The shortened infusion time of intravenous ibuprofen, part 2: a multicenter, open-label, surgical surveillance trial to evaluate safety. Clin Ther. 2015 Feb 1;37(2):368-75. doi: 10.1016/j.clinthera.2014.12.006. Epub 2015 Jan 13.
PMID: 25592331DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Amy Rock
- Organization
- Cumberland Pharmaceuticals Inc.
Study Officials
- STUDY DIRECTOR
Art P Wheeler, M.D.
Cumberland Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2011
First Posted
April 13, 2011
Study Start
June 1, 2011
Primary Completion
December 1, 2012
Study Completion
January 1, 2013
Last Updated
February 28, 2024
Results First Posted
June 23, 2014
Record last verified: 2024-02