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

Pain Clinical Trial

Official title:

A Multi-Center, Open-Label, Surgical Surveillance Trial To Evaluate The Safety And Efficacy Of A Shortened Infusion Time of Intravenous Ibuprofen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01334957
• Other study ID #: CPI-CL-016
• Status: Completed
• Phase: Phase 4
• Start date: June 2011
• Est. completion date: January 2013

Study information

• Verified date: February 2024
• Source: Cumberland Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Intravenous ibuprofen
800 mg intravenous ibuprofen administered intravenously over 5-10 minutes

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	State of New York Downstate Medical Center (SUNY)	Brooklyn	New York
United States	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	RUSH Univ. Medical Center	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	Parkland Memorial	Dallas	Texas
United States	Detroit Medical Center	Detroit	Michigan
United States	Duke University Health System	Durham	North Carolina
United States	Hendersonville Hospital/Comprehensive Pain Specialists	Hendersonville	Tennessee
United States	Penn State College of Medicine	Hershey	Pennsylvania
United States	Univ. of Kansas Medical Center	Kansas City	Kansas
United States	UC San Diego Regional Center	La Jolla	California
United States	North Shore - Long Island Jewish Health System	Manhasset	New York
United States	University of Miami Health System	Miami	Florida
United States	Neurovations (Queen of the Valley Hospital)	Napa	California
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Sheridan Clinical Research	Plantation	Florida
United States	North Mississippi Sports Medicine & Orthopaedic Clinic	Tupelo	Mississippi
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	To Determine the Safety of a Multiple Doses 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 last dose of intravenous ibuprofen	6 hours
Secondary	To Determine the Safety of a Multiple Doses 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 last dose of intravenous ibuprofen	6 hours
Secondary	To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.	Visual Analog Scale (VAS) assessments following surgery. The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between o and 100.	6 hours