Moore Paul A, Brar Pardeep, Smiga Eric R, Costello Bernard J
Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Feb;99(2):E1-7. doi: 10.1016/j.tripleo.2004.08.028.
Objective The goal of this preliminary randomized prospective clinical trial was to compare the analgesic efficacy and the reduction in trismus of preoperative rofecoxib, intraoperative dexamethasone, and both rofecoxib and dexamethasone following third molar extraction surgery. Study design Thirty-five subjects requiring surgical removal of at least 1 partial bony impacted mandibular third molar were invited to participate in this double-blind and double-dummy placebo-controlled clinical trial. Subjects were randomly assigned into 1 of 4 treatment groups: (1) placebo po preoperatively and placebo IV intraoperatively; (2) rofecoxib 50 mg po preoperatively and placebo IV intraoperatively; (3) placebo po preoperatively and dexamethasone10 mg IV intraoperatively; and (4) rofecoxib 50 mg po preoperatively and dexamethasone 10 mg IV intraoperatively. Subjects completed a diary assessing postoperative pain onset and intensity using categorical and visual analogue scales. Interincisal opening was assessed 1, 2, 3, and 7 days postoperatively using a Therabite ruler. Results This randomized controlled clinical trial enrolled 35 subjects. Two subjects did not meet the inclusion criteria and 4 did not return completed diaries. The mean age of the remaining 29 subjects (11 males, 18 females) was 22.8 years (+/- 0.6 year). The active treatments tended to delay the need for initial pain medication. When compared to other active treatments and to placebo, the combination of preoperative rofecoxib and intraoperative dexamethasone significantly reduced initial pain intensity ( P < .05). Baseline interincisal opening was 52.6 mm (+/- 6.2). The greatest decrease in interincisal opening was 43.3% for the placebo group at 24 hours. Preoperative rofecoxib alone showed a decrease in interincisal opening of 42.3% ( P = ns) at 24 hours. Intraoperative dexamethasone alone showed a decrease in the interincisal opening of 24.1% of baseline ( P < .05 vs placebo). The group receiving the combination of rofecoxib and dexamethasone showed a decrease in interincisal opening of 23.7% of baseline ( P < .05 vs placebo). Conclusions The results of this trial indicate that the use of intraoperative dexamethasone is an effective therapeutic strategy for limiting trismus following surgical removal of impacted third molars. The combination of preoperative rofecoxib 50 mg and intraoperative dexamethasone 10 mg was most effective in minimizing pain and trismus following third molar surgery.
本初步随机前瞻性临床试验的目的是比较术前罗非昔布、术中地塞米松以及罗非昔布与地塞米松联合应用于第三磨牙拔除术后的镇痛效果及牙关紧闭的减轻情况。
邀请35名需要手术拔除至少1颗部分骨埋伏下颌第三磨牙的受试者参与这项双盲、双模拟、安慰剂对照的临床试验。受试者被随机分为4个治疗组中的1组:(1)术前口服安慰剂,术中静脉注射安慰剂;(2)术前口服50mg罗非昔布,术中静脉注射安慰剂;(3)术前口服安慰剂,术中静脉注射10mg地塞米松;(4)术前口服50mg罗非昔布,术中静脉注射10mg地塞米松。受试者使用分类和视觉模拟量表完成一份日记,评估术后疼痛的发作和强度。术后1、2、3和7天使用Therabite尺评估切牙间开口度。
这项随机对照临床试验纳入了35名受试者。2名受试者不符合纳入标准,4名未返回完整的日记。其余29名受试者(11名男性,18名女性)的平均年龄为22.8岁(±0.6岁)。积极治疗倾向于延迟首次使用止痛药物的时间。与其他积极治疗和安慰剂相比,术前罗非昔布与术中地塞米松联合应用显著降低了初始疼痛强度(P<0.05)。基线切牙间开口度为52.6mm(±6.2)。安慰剂组在24小时时切牙间开口度最大降幅为43.3%。单独术前使用罗非昔布在24小时时切牙间开口度降幅为42.3%(P=无统计学意义)。单独术中使用地塞米松切牙间开口度较基线下降24.1%(与安慰剂相比P<0.05)。接受罗非昔布与地塞米松联合治疗的组切牙间开口度较基线下降23.7%(与安慰剂相比P<0.05)。
本试验结果表明,术中使用地塞米松是限制埋伏第三磨牙拔除术后牙关紧闭的有效治疗策略。术前50mg罗非昔布与术中10mg地塞米松联合应用在减轻第三磨牙手术后疼痛和牙关紧闭方面最有效。