Safety Evaluation of IVIB
All NSAIDs contain label warnings and precautions regarding the risk of
gastrointestinal bleeding or ulceration, cardiovascular risks, renal and
hepatic injury, and bleeding related to platelet dysfunction (67, 68).
Nevertheless, these AEs are predominantly connected to long-term drug
use, whereas acute perioperative use of NSAIDs is considered relatively
safe. Overall, IVIB had not demonstrated increased risk of SAEs,
including hematological and renal system, in pain and fever management
according to our analyses. It showed a decreased risk of nausea or
vomiting, probably owing to the lower cumulative consumption of opioid
medication in multimodal analgesia management (69). Furthermore, the
elderly patients who received IVIB also experienced far fewer AEs
overall (59%) than did those receiving placebo (94%)
(50 ). In pediatric population, the
majority of AEs were mild to moderate, and there was no significant
difference between IVIB and intravenous acetaminophen (70, 71).
It is worth mentioning that several studies have investigated the safety
of single and multiple doses of IVIB administered over 5 to 10 minutes
other than 30 minutes recommended for the treatment of postoperative
pain in health adults. They found that 22%~29% of
patients experienced AEs, and the most common AE was infusion site pain
(11%~15%). No deaths or IVIB-related SAEs were
reported (72, 73). Also, studies assessed the safety and acceptability
of 5- to 10-minute infusion of IVIB and found that it appeared a faster
efficacy in reducing fever compared to acetaminophen administered at a
regular pace (41, 66). IVIB rapid infusion was therefore proved be well
tolerated and proved additional benefits in the perioperative period and
emergent situations.