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

Cumberland Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Intravenous ibuprofen

Study type: Interventional

Funder types: Industry

Identifiers

NCT01334957

CPI-CL-016

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Intravenous ibuprofen

Experimental group

Description:

Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.

Treatment:

Drug: Intravenous ibuprofen