The Safety and Efficacy of Intravenous Ibuprofen in Older Patients: A Retrospective Subgroup Analysis

Abstract

Purpose: Intravenous ibuprofen (IVIB) is safe and effective for the management of pain and fever in children and adults, but requires evaluation in older patients. This retrospective study aimed to evaluate the safety and efficacy of IVIB in older patients (age ≥60 years).

Methods: A post hoc subgroup analysis was performed with data from four prospective clinical studies in which IVIB was administered for the treatment of pain and/or fever in hospitalized patients every 6 hours for up to 5 days. Efficacy was assessed using total morphine requirement and the visual analogue scale to evaluate pain. Safety was assessed by adverse event (AE) monitoring.

Findings: Of 1041 patients treated, 757 patients were 18 to 59 years old and 284 were ≥60 years old. Among older patients, 61 received placebo, and 223 received IVIB. All patients were included in the safety assessment; 591 patients from two placebo-controlled trials were included in the efficacy analysis. In both age cohorts, the incidence of AEs was higher in the placebo group, and the incidence of serious AEs was similar between treatment groups. In older patients, IVIB treatment resulted in a 24.0% reduction in pain at rest (P = 0.008), a 20.0% reduction in pain with movement (P = 0.001) between 6 and 24 hours postsurgery, and a 23.2% reduction in total morphine requirement (P = 0.031) compared with placebo.

Implications: IVIB was well-tolerated and reduced postoperative opioid consumption and pain severity in older patients. These findings suggest IVIB is a safe and effective nonopioid analgesic for perioperative pain management in older individuals.

Keywords: NSAIDs; analgesics; ibuprofen; older adults; pain.