Many studies have demonstrated the postoperative analgesic efficacy of fentanyl delivered i.v. by patient-controlled analgesia (PCA) devices at demand doses ranging from 10 to 50 microg, but none has sought to define the optimal fentanyl PCA dose. In this randomized, double-blind, multicenter study, we compared the safety and efficacy of three administered demand-dose sizes of fentanyl (20, 40, and 60 microg) in 150 patients after major surgery. Efficacy was dose-dependent; positive response rates (i.e., a global assessment score of "very good" or "excellent" and the absence of severe opioid adverse effects) were 42%, 52%, and 68% for the 20, 40, and 60 microg demand-dose groups, respectively, and were significantly higher in the 60 microg demand-dose group. The number of doses administered and missed attempts were significantly smaller in the 40 and 60 microg demand-dose groups compared with the 20 microg demand-dose group. This suggests that the 20 microg demand dose provided inadequate pain relief. Adverse respiratory events were more frequent and mean respiratory rates were significantly slower with the 60 microg demand dose, compared with the 20 or 40 microg demand doses. These results indicate that, of these three doses, the 40 microg demand dose was optimal for fentanyl PCA management of moderate to severe pain after major surgery.
Implications: The postoperative analgesic efficacy of fentanyl delivered i.v. by patient-controlled analgesia devices has been demonstrated for demand doses ranging from 10 to 50 microg, but the optimal fentanyl dose remains unknown. In this randomized, double-blind study, we compared three demand dose sizes of fentanyl (20, 40, and 60 microg) and found that the 40 microg demand dose was the most appropriate for fentanyl patient-controlled analgesia management of postoperative pain.