Clinical trial NCT01334957: Surgical Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen
Official title: A Multi-Center, Open-Label, Surgical Surveillance Trial To Evaluate The Safety And Efficacy Of A Shortened Infusion Time of Intravenous Ibuprofen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-04-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for surgery with anticipated need for postoperative analgesia

Exclusion Criteria:

1. Patients with inadequate IV access
2. Patients \<18 years of age
3. History or allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin (or aspirin related products) or non-steroidal anti-inflammatory drug (NSAIDs)
4. Active hemorrhage or clinically significant bleeding
5. Pregnant or nursing
6. Patients in the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery
7. 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
8. Refusal to provide written authorization for use and disclosure of protected health information

Primary outcomes:
measure: To Determine the Safety of a Single Dose of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.
timeFrame: 6 hours
measure: To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.
timeFrame: 6 hours
Secondary outcomes:
measure: To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.
timeFrame: 6 hours
measure: To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.
timeFrame: 6 hours
measure: To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.
timeFrame: 6 hours
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego Regional Center
state: California
city: Napa
country: United States
facility: Neurovations (Queen of the Valley Hospital)
state: California
city: Miami
country: United States
facility: University of Miami Health System
state: Florida
city: Plantation
country: United States
facility: Sheridan Clinical Research
state: Florida
city: Chicago
country: United States
facility: RUSH Univ. Medical Center
state: Illinois
city: Kansas City
country: United States
facility: Univ. of Kansas Medical Center
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Detroit Medical Center
state: Michigan
city: Tupelo
country: United States
facility: North Mississippi Sports Medicine & Orthopaedic Clinic
state: Mississippi
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Brooklyn
country: United States
facility: State of New York Downstate Medical Center (SUNY)
state: New York
city: Manhasset
country: United States
facility: North Shore - Long Island Jewish Health System
state: New York
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Hershey
country: United States
facility: Penn State College of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Hendersonville
country: United States
facility: Hendersonville Hospital/Comprehensive Pain Specialists
state: Tennessee
city: Dallas
country: United States
facility: Parkland Memorial
state: Texas
Study officials:
affiliation: Cumberland Pharmaceuticals, Inc.
name: Art P Wheeler, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.