The opioid-sparing IVIB pain management strategy in adults aged 60 and older was effective in the immediate post-surgical period and associated with limited AEs.
Intravenous ibuprofen (IVIB) was found safe and effective for pain reduction in adults aged 60 years and older and led to a 23.3% reduction in postoperative opioid consumption, according to a new analysis published in Clinical Therapeutics. Compared with placebo, treatment with the IV formulation (Calodor; Cumberland Pharmaceuticals) reduced pain at rest by 24% (P =.008) and pain with movement by 20% (P =.001) within a critical postperative window of 6 to 24 hours.
The findings, drawn from a post-hoc subgroup analysis of 4 prospective clinical studies that assessed IVIB for treatment of pain and/or fever in hospitalized patients, address a significant unmet need in pain management for older adults, a group often underrepresented in clinical trials despite undergoing nearly one-third of all ambulatory surgeries, according to study authors, led by Tong Joo Gan, MD, MBA, division head of anesthesiology, critical care and pain medicine at MD Anderson Cancer Center, in Houston, TX.
The efficacy assessment involved 591 patients from 2 of the placebo-controlled trials, while safety outcomes were evaluated across all 1,041 individuals enrolled across the studies.
IVIB was administered for the treatment of pain and/or fever 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.
Adverse events occurred in 55% of IVIB-treated participants versus 90% in the placebo group, according to the study. Joo and colleagues reported no notable increases in gastrointestinal, renal, cardiovascular, or bleeding complications among participants who received IVIB. Despite older patients receiving higher cumulative doses, the drug’s safety and efficacy profiles remained consistent with those observed in younger cohorts.
“These results provide compelling evidence that intravenous ibuprofen is both safe and effective for managing post-operative pain in older patients,” Joo said in a statement. He emphasized the importance of reducing opioid exposure in this population, who are particularly susceptible to falls, respiratory depression, and cognitive impairment.
"We've long recognized the need for effective non-opioid analgesic options for older surgical patients," coauthor Stephen Southworth, MD, an orthopaedic surgeon at Orthopaedic Institute of North Mississippi, added in the statement. “This analysis demonstrates that [IVIB] not only reduces pain intensity but also decreases the need for opioid medication, potentially improving overall recovery outcomes in this growing demographic.
"The majority of pain from injury and surgery is inflammatory in nature and is unaddressed by opioids which is why [IVIB] has become a cornerstone of our multi-modal pain regimen.”
IVIB is already FDA-approved for managing mild to moderate pain, adjunct treatment for moderate to severe pain, and fever reduction in patients three months and older. These new findings specifically support its expanded use in older adults.