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Surgical Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen

Information source: Cumberland Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Intravenous ibuprofen (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Cumberland Pharmaceuticals

Official(s) and/or principal investigator(s):
Art P Wheeler, M.D., Study Director, Affiliation: Cumberland Pharmaceuticals Inc.

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.

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

To Determine the Safety of a Single Dose of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.

To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.

Secondary outcome:

To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.

To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.

To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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

Additional Information

Starting date: June 2011
Last updated: May 20, 2014

Page last updated: August 23, 2015

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