Ong Cliff K S, Lirk Phillip, Tan Juliana M H, Sow Belle W Y
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, National University of Singapore, Singapore.
J Oral Maxillofac Surg. 2005 Aug;63(8):1162-8. doi: 10.1016/j.joms.2005.04.028.
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.
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).
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.
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.
本研究旨在比较单剂量术前静脉注射与口服曲马多预防第三磨牙手术后疼痛的镇痛效果。
72例行择期第三磨牙手术的患者被随机分为两组,每组36例,分别接受静脉注射(n = 36)或口服(n = 36)50 mg曲马多。静脉注射组术前先口服一粒安慰剂胶囊,然后静脉注射50 mg曲马多。口服曲马多组术前先口服一粒50 mg曲马多胶囊,然后静脉注射安慰剂生理盐水。两组均采用标准静脉镇静技术,在局部麻醉下拔除阻生第三磨牙。通过4个主要终点评估术后疼痛差异:用100 mm视觉模拟量表测量8小时内的每小时疼痛强度、使用解救镇痛药的时间、术后对乙酰氨基酚的消耗量以及5分整体评估量表(0 = 差,1 = 一般,2 = 好,3 = 非常好,4 = 优秀)。
在整个8小时的研究期间,静脉注射组患者报告的疼痛强度评分显著低于口服组(15.9±9.6 mm对36.9±17.2 mm,P = 0.03)。静脉注射组患者报告的使用解救镇痛药的时间也显著更长(7.0小时对3.5小时,P = 0.00001),术后对乙酰氨基酚的消耗量更少(1823±1266 mg对3558±1418 mg,P = 0.000006),整体评估更好(2.6±0.9对1.1±0.8,P = 0.01)。
我们得出结论,术前静脉注射曲马多在预防第三磨牙手术后疼痛方面优于口服曲马多。然而,应该注意的是,两种剂型的生物利用度相差高达30%,这可能解释了研究结果。