Our review revealed a great heterogeneity in definition , format , and values of what is considered a clinical ly relevant difference in pain in RCTs of analgesics , and st and ardizations are advisable
OBJECTIVE To describe the  pain decrease considered as clinical ly relevant when design ing a trial and reporting its results .
The analgesic efficacy of intravenous versus oral tramadol for preventing postoperative pain after third molar surgery.
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 r and omized 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 st and ard 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
Our review revealed a great heterogeneity in definition , format , and values of what is considered a clinical ly relevant difference in pain in RCTs of analgesics , and st and ardizations are advisable
OBJECTIVE To describe the  pain decrease considered as clinical ly relevant when design ing a trial and reporting its results .