A Randomized Trial Comparing the Safety and Efficacy of Intravenous Ibuprofen versus Ibuprofen and Acetaminophen in Knee or Hip Arthroplasty.

BACKGROUND: All surgical procedures are associated with a degree of pain. The experience of uncontrolled post-operative pain can have significant implications on health care costs. Recent studies have demonstrated that intravenous (IV) ibuprofen is an effective, safe, well-tolerated analgesic when administered for both abdominal hysterectomy and orthopedic surgery. The use of ibuprofen leads to a reduction in pain severity at rest and with movement and also decreases narcotic consumption. IV acetaminophen has also been shown to be effective in alleviating pain for surgical procedures. Given the established safety and efficacy of IV ibuprofen and IV acetaminophen for perioperative pain, we were interested in determining if any potential synergies are afforded by the simultaneous administration of both medications in orthopedic surgery patients.
OBJECTIVES: Compare the safety and efficacy of the perioperative administration of IV ibuprofen alone and in combination with IV acetaminophen in total knee or hip arthroplasty. STUDY
DESIGN: Randomized, single center, trial.
SETTING: Tertiary care center in Philadelphia, Pennsylvania, United States.
METHODS: Seventy-eight patients undergoing elective knee or hip arthroplasty were randomized into 2 groups. Group 1 received 800 mg of IV ibuprofen at induction, and 800 mg of IV ibuprofen every 6 hours until discharge or for up to 5 days. Group 2 received 800 mg IV ibuprofen at induction and 1000 mg IV acetaminophen at closure, and 800 mg IV ibuprofen plus 1000 mg IV acetaminophen every 6 hours until discharge for up to 5 days. The primary endpoint was demonstrated using the visual analog scale (VAS) pain scores. Secondary endpoints included opioid requirements, quality of recovery scale (QoR), length of post-anesthesia care unit (PACU) stay, antiemetic consumption, opioid consumption, and opioid related adverse events.
RESULTS: Patients in Group 2 had lower VAS scores (P < 0.002) by day 3 only. Opioid requirements and adverse events were significantly less in Group 2 which was also statistically significant. Time to discharge from the PACU for Group 1 on average was 55 minutes and 38 minutes for Group 2 (P = 0.178) which was not statistically significant although may have clinical significance. Length of hospital stay was also evaluated; however, no statistical significance was noted between the 2 groups (P = 0.138). There was no significant difference in QoR scores which were 177 (SD = 15.44) for Group 1 (n = 35) and 179.5 (SD = 16.30) for Group 2 (n = 39). LIMITATIONS: The study is a single center study with the attendant risk of convenience bias. The total number of patients is also small and may call into question the reproducibility of the results. No cost analysis was undertaken as part of this study. Further research should aim at prospectively designed multi-center double blinded randomized control trials with an analysis of the pharmacoeconomics of the use of these agents.
CONCLUSION: IV ibuprofen combined with IV acetaminophen demonstrated additional benefit in terms of improved pain scores on post-operative day 3 only, fewer potential adverse events related to opioid use, and decreased use of opioids when compared to IV ibuprofen alone.

RCT Entities:   Population Interventions Outcomes