Mar. 9, 2010

A Multi-Center, Randomized, Double-Blind Placebo-Controlled Trial of Ibuprofen Injection for Treatment of Pain in Post-Operative Orthopedic Adult Patients


A multimodal approach to pain management has been proposed as a means of achieving comprehensive pain relief, while minimizing the potential for opioid-related adverse effects by lowering the total dose of opioid that is required.

An intravenous formulation of ibuprofen, Caldolor® (ibuprofen) Injection, has recently been approved by the US Food and Drug Administration (FDA) for use in adults for treatment of mild to moderate pain, moderate to severe pain as an adjunct to opioid medications and reduction of fever. Oral ibuprofen is a widely used, generally well tolerated, and effective NSAID with analgesic, antipyretic and anti-inflammatory properties.

However, oral administration is not practical during the immediate pre- and postoperative periods. This study was conducted to assess the tolerability and efficacy of pre- and postoperatively administered IV ibuprofen in the management of pain control as measured by the patients’ self-assessment of pain and by the reduction of opioid use in patients after elective orthopedic surgical procedures.

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