4.1. Study limitations
pain
ADVERSE EVENTS, ADVERSE REACTION
Several limitations of this study should be addressed. First, this study tested the postoperative analgesic effects of SDE that was administered after induction of anesthesia rather than > 12 hours before surgical intervention. According to the clinical pharmacokinetics of SDE, plasma therapeutic levels of nalbuphine are achieved at 12 hours after intramuscular injection.In conclusion, a single dose of the extended-release analgesic SDE administered intra-operatively did not provide a sufficient add-on effect to the standard MMA for acute and chronic postsurgical pain after laparoscopic cholecystectomy. On the contrary, intramuscular injection of 150 mg SDE in patients with average body mass can cause certain adverse events that may have been overlooked in previous reports. The adverse reaction profile and appropriate dosing of SDE should be more thoroughly investigated.