PURPOSE: To assess the safety and efficacy of transdermal fentanyl plus im ketorolac vs im ketorolac alone in the treatment of postoperative pain. METHODS:Ninety-two patients scheduled for surgery involving moderate to severe postoperative pain were randomized to one of two groups. Group A (n = 46) received an active fentanyl patch and group P (n = 46) received a placebo patch. Patches remained in place for 24 hr. Each patient received intraoperative ketorolac, 60 mg im. Patients were monitored for 36 hr postoperatively and the groups were analyzed for ketorolac usage, pain scores, vital signs, serum fentanyl concentrations, and adverse events. Intramuscular ketorolac was available on demand. RESULTS: Group A had lower pain scores at 8.12, 16 and 24 hr after patch placement (P < 0.05). Group A had lower heart rates, lower respiratory rates and fewer dropouts due to inadequate pain relief (4.3% vs 21.7% P < 0.05). Group A patients also used less ketorolac than group P patients (P < 0.05). The incidence of pruritus was higher in group A patients (19% vs 2%, P < 0.05), while the incidence of nausea and vomiting was not different between the two groups. Transdermal fentanyl was adequate "stand-alone" analgesia in only 23.8% of group A patients while 93.7% of the remaining group A patients receiving a combination of transdermal fentanyl and ketorolac had adequate pain relief. CONCLUSION: The transdermal fentanyl delivery system plus ketorolac im was more effective in controlling post-operative pain than ketorolac im alone. The two treatment modalities were comparable in safety with no difference in serious adverse events.
RCT Entities:
PURPOSE: To assess the safety and efficacy of transdermal fentanyl plus im ketorolac vs im ketorolac alone in the treatment of postoperative pain. METHODS: Ninety-two patients scheduled for surgery involving moderate to severe postoperative pain were randomized to one of two groups. Group A (n = 46) received an active fentanyl patch and group P (n = 46) received a placebo patch. Patches remained in place for 24 hr. Each patient received intraoperative ketorolac, 60 mg im. Patients were monitored for 36 hr postoperatively and the groups were analyzed for ketorolac usage, pain scores, vital signs, serum fentanyl concentrations, and adverse events. Intramuscular ketorolac was available on demand. RESULTS: Group A had lower pain scores at 8.12, 16 and 24 hr after patch placement (P < 0.05). Group A had lower heart rates, lower respiratory rates and fewer dropouts due to inadequate pain relief (4.3% vs 21.7% P < 0.05). Group A patients also used less ketorolac than group P patients (P < 0.05). The incidence of pruritus was higher in group A patients (19% vs 2%, P < 0.05), while the incidence of nausea and vomiting was not different between the two groups. Transdermal fentanyl was adequate "stand-alone" analgesia in only 23.8% of group A patients while 93.7% of the remaining group A patients receiving a combination of transdermal fentanyl and ketorolac had adequate pain relief. CONCLUSION: The transdermal fentanyl delivery system plus ketorolac im was more effective in controlling post-operative pain than ketorolac im alone. The two treatment modalities were comparable in safety with no difference in serious adverse events.