PURPOSE: The aim of this study was to compare the analgesic efficacy of single-dose preoperative intravenous versus oral tramadol for preventing pain after third molar surgery. PATIENTS AND METHODS: Seventy-two patients undergoing elective third molar surgery were randomized to receive either intravenous (n = 36) or oral (n = 36) tramadol 50 mg. The intravenous group received an oral placebo capsule followed by intravenous tramadol 50 mg preoperatively. The oral tramadol group received a 50-mg oral tramadol capsule followed by intravenous placebo saline preoperatively. In both groups, a standard intravenous sedation technique was administered and the impacted third molars were removed under local anesthesia. The difference in postoperative pain was assessed by 4 primary end points: hourly pain intensity as measured by a 100-mm visual analog scale for 8 hours, time to rescue analgesic, postoperative acetaminophen consumption, and a 5-point global assessment scale (0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent). RESULTS: Throughout the 8-hour investigation period, patients reported significantly lower pain intensity scores in the intravenous versus oral group (15.9 +/- 9.6 mm versus 36.9 +/- 17.2 mm, P = .03). Patients also reported significantly longer time to rescue analgesic (7.0 hours versus 3.5 hours, P = .00001), lesser postoperative acetaminophen consumption (1,823 +/- 1,266 mg versus 3,558 +/- 1,418 mg, P = .000006), and better global assessment (2.6 +/- 0.9 versus 1.1 +/- 0.8, P = .01) for the intravenous versus oral group. CONCLUSIONS: We conclude that preoperative intravenous tramadol is superior to oral tramadol for preventing postoperative pain following third molar surgery. However, it should be noted that there is a difference in the bioavailability between the 2 formulations of up to 30%, which may explain the findings.
RCT Entities:
PURPOSE: The aim of this study was to compare the analgesic efficacy of single-dose preoperative intravenous versus oral tramadol for preventing pain after third molar surgery. PATIENTS AND METHODS: Seventy-two patients undergoing elective third molar surgery were randomized to receive either intravenous (n = 36) or oral (n = 36) tramadol 50 mg. The intravenous group received an oral placebo capsule followed by intravenous tramadol 50 mg preoperatively. The oral tramadol group received a 50-mg oral tramadol capsule followed by intravenous placebo saline preoperatively. In both groups, a standard intravenous sedation technique was administered and the impacted third molars were removed under local anesthesia. The difference in postoperative pain was assessed by 4 primary end points: hourly pain intensity as measured by a 100-mm visual analog scale for 8 hours, time to rescue analgesic, postoperative acetaminophen consumption, and a 5-point global assessment scale (0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent). RESULTS: Throughout the 8-hour investigation period, patients reported significantly lower pain intensity scores in the intravenous versus oral group (15.9 +/- 9.6 mm versus 36.9 +/- 17.2 mm, P = .03). Patients also reported significantly longer time to rescue analgesic (7.0 hours versus 3.5 hours, P = .00001), lesser postoperative acetaminophen consumption (1,823 +/- 1,266 mg versus 3,558 +/- 1,418 mg, P = .000006), and better global assessment (2.6 +/- 0.9 versus 1.1 +/- 0.8, P = .01) for the intravenous versus oral group. CONCLUSIONS: We conclude that preoperative intravenous tramadol is superior to oral tramadol for preventing postoperative pain following third molar surgery. However, it should be noted that there is a difference in the bioavailability between the 2 formulations of up to 30%, which may explain the findings.