Sener Mesut, Ozgur Pektas Zafer, Yilmaz Ismail, Turkoz Ayda, Uckan Sina, Donmez Asli, Arslan Gulnaz
Department of Anesthesiology and Reanimation, Faculty of Medicine, Baskent University, Ankara, Turkey.
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, easkent University, Ankara, Turkey.
Curr Ther Res Clin Exp. 2005 Nov;66(6):541-51. doi: 10.1016/j.curtheres.2005.12.001.
Preemptive analgesia used for postsurgical pain management has been shown to reduce the requirements of postoperative analgesics.
The aim of this study was to compare the preemptive analgesic effects of diflunisal, naproxen sodium, meloxicam, acetaminophen, and rofecoxin (no longer available in some markets) in patients undergoing ambulatory dental surgery and the need for postoperative pain management in these patients.
This prospective, randomized, single-blind study was conducted at the Departments of Anesthesiology and Reanimation and Oral and Maxillofacial Surgery, Baskent University, Adana Teaching and Medical Research Center, Adana, Turkey. Turkish outpatients aged ≥ 16 years with American Society of Anesthesiologists physical status 1 (ie, healthy) and scheduled to undergo surgical extraction of an impacted third molar were enrolled. Patients were randomly assigned to receive diflunisal 500 mg, naproxen sodium 550 mg, meloxicam 7.5 mg, acetaminophen 500 mg, or rofecoxib 12.5 mg. All medications were administered orally 1 hour before surgery as preemptive analgesia and after surgery if needed, up to the maximum recommended dose. Surgery was performed with the patient under local anesthesia (articaine hydrochloride). Pain intensity was assessed using a 100-mm visual analog scale (VAS) (0 = none to 100 = worst possible pain) at 2, 4, 6, and 12 hours after ambulatory surgery. The use of additional analgesics was recorded for 24 hours using patient diaries. Postoperative adverse events were recorded using the diaries.
One hundred fifty patients (108 women, 42 men; mean [SE] age, 26.8 [0.6] years; 30 patients per group) had data available for analysis. Demographic data were similar between the 5 groups. No significant differences in mean VAS scores were found between the 5 groups at any time point. All mean VAS scores indicated minor pain. The rate of additional postoperative analgesics required was significantly lower in the diflunisal group compared with groups receiving naproxen sodium, meloxicam, acetaminophen, and rofecoxib (3 [10%] patients vs 11 [37%], 15 [50%], 15 [50%], and 14 [47%] patients, respectively; all, P < 0.05). Bleeding at the surgical site was reported in 2 patients each in the diflunisal, naproxen sodium, meloxicam, and acetaminophen groups, and in 1 patient in the rofecoxib group; the between-group differences were not significant. No significant differences in the prevalences of other adverse effects (eg, nausea, vomiting, allergy, gastrointestinal symptoms) were found between the 5 treatment groups.
In the present study in patients undergoing third molar extraction, adequate preemptive analgesia, based on VAS scores, was found with all of the nonopioid analgesic agents used. Fewer patients required rescue medication with diflunisal. All 5 study drugs were similarly well tolerated.
用于术后疼痛管理的超前镇痛已被证明可减少术后镇痛药的需求。
本研究旨在比较双氯芬酸、萘普生钠、美洛昔康、对乙酰氨基酚和罗非考昔(在某些市场已不再可用)对接受非住院牙科手术患者的超前镇痛效果以及这些患者术后疼痛管理的需求。
这项前瞻性、随机、单盲研究在土耳其阿达纳教学与医学研究中心巴什肯特大学麻醉与复苏科及口腔颌面外科进行。纳入年龄≥16岁、美国麻醉医师协会身体状况分级为1级(即健康)且计划接受阻生第三磨牙手术拔除的土耳其门诊患者。患者被随机分配接受双氯芬酸500毫克、萘普生钠550毫克、美洛昔康7.5毫克、对乙酰氨基酚500毫克或罗非昔布12.5毫克。所有药物均在手术前1小时口服作为超前镇痛,术后必要时服用,直至最大推荐剂量。手术在患者局部麻醉(盐酸阿替卡因)下进行。在非住院手术后2、4、6和12小时,使用100毫米视觉模拟量表(VAS)(0 = 无疼痛至100 = 可能的最严重疼痛)评估疼痛强度。使用患者日记记录24小时内额外镇痛药的使用情况。使用日记记录术后不良事件。
150例患者(108例女性,42例男性;平均[标准误]年龄,26.8[0.6]岁;每组30例患者)有可供分析的数据。5组之间的人口统计学数据相似。在任何时间点,5组之间的平均VAS评分均未发现显著差异。所有平均VAS评分均表明为轻度疼痛。与接受萘普生钠、美洛昔康、对乙酰氨基酚和罗非考昔的组相比,双氯芬酸组术后所需额外镇痛药的比例显著更低(分别为3[10%]例患者对11[37%]例、15[50%]例、15[50%]例和14[47%]例患者;均P<0.05)。双氯芬酸、萘普生钠、美洛昔康和对乙酰氨基酚组各有2例患者报告手术部位出血,罗非考昔组有1例患者报告手术部位出血;组间差异不显著。5个治疗组之间在其他不良反应(如恶心、呕吐、过敏、胃肠道症状)的发生率方面未发现显著差异。
在本项针对接受第三磨牙拔除术患者的研究中,发现所有使用的非阿片类镇痛药基于VAS评分均能提供充分的超前镇痛。使用双氯芬酸需要救援药物的患者较少。所有5种研究药物的耐受性相似。