Seymour R A, Hawkesford J E, Sykes J, Stillings M, Hill C M
Department of Restorative Dentistry, Dental School, University of Newcastle, Newcastle upon Tyne, England. R. A.
Br Dent J. 2003 Feb 8;194(3):153-7; discussion 149. doi: 10.1038/sj.bdj.4809898.
To compare the efficacy of soluble aspirin 900 mg and paracetamol 1,000 mg in patients with postoperative pain after third molar surgery.
A randomised, placebo controlled, double-blind study.
Day stay units of Oral and Maxillofacial Surgery at Cardiff Dental Hospital and Hexham General Hospital, Northumberland.
One hundred and sixty-seven (104 female) patients who required the removal of their impacted third molars under general anaesthesia.
In the early postoperative period, patients were medicated with either a single dose of soluble aspirin 900 mg, solid paracetamol 1,000 mg or placebo.
Pain intensity was measured on 100 mm visual analogue scales at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120 and 240 minutes after dosing. Other efficacy variables evaluated included time to rescue medication and an overall assessment of the study medication efficacy by the patient on completion of the study.
One hundred and sixty-seven patients consented to take part in the study, but only 153 were medicated. Of the 14 patients not treated, 10 failed to develop sufficient pain to enter the study, two withdrew consent, one had an adverse reaction to the general anaesthetic and one was a protocol violator. Over the four hour investigation period, patients treated with soluble aspirin reported significantly less pain when compared with those treated with paracetamol (mean difference in AUC(0-240) = -2001, 95% CI -3893 to -109, p=0.038) and placebo (mean difference in AUC(0-240) = -3470, 95% CI -5719 to -1221, p=0.003). Similarly, at 20 and 30 minutes after dosing, patients in the soluble aspirin group were reporting significantly less pain than those in the paracetamol treatment group (mean difference in pain intensity: at 20 minutes -7.9, 95% CI -15.3 to -0.6, p=0.035; at 30 minutes -10.6, 95% CI -18.6 to -2.6, p=0.010). There were no significant differences between treatment groups with respect to the number of patients requiring rescue medication, however the time to dosing was significantly longer for those taking soluble aspirin when compared with placebo (hazard ratio 2.34, 95% CI 1.41 to 3.88, p<0.001).
The findings from this study showed that soluble aspirin 900 mg provides significant and more rapid analgesia than paracetamol 1,000 mg in the early postoperative period after third molar surgery.
比较900毫克可溶性阿司匹林与1000毫克对乙酰氨基酚对第三磨牙手术后患者术后疼痛的疗效。
一项随机、安慰剂对照、双盲研究。
加的夫牙科医院和诺森伯兰郡赫克瑟姆综合医院的口腔颌面外科日间病房。
167名(104名女性)需要在全身麻醉下拔除阻生第三磨牙的患者。
术后早期,患者分别服用单剂量的900毫克可溶性阿司匹林、1000毫克对乙酰氨基酚固体或安慰剂。
给药后0、5、10、15、20、30、45、60、90、120和240分钟,使用100毫米视觉模拟量表测量疼痛强度。评估的其他疗效变量包括使用急救药物的时间以及患者在研究结束时对研究药物疗效的总体评估。
167名患者同意参与研究,但只有153名接受了药物治疗。在未接受治疗的14名患者中,10名患者疼痛程度不足,无法进入研究,2名撤回同意,1名对全身麻醉有不良反应,1名违反方案。在4小时的研究期间,与服用对乙酰氨基酚的患者相比,服用可溶性阿司匹林的患者报告的疼痛明显更少(AUC(0 - 240)的平均差异 = -2001,95%置信区间 -3893至 -109,p = 0.038),与服用安慰剂的患者相比也是如此(AUC(0 - 240)的平均差异 = -3470,95%置信区间 -5719至 -1221,p = 0.003)。同样,在给药后20和30分钟,可溶性阿司匹林组的患者报告的疼痛明显少于对乙酰氨基酚治疗组(疼痛强度的平均差异:20分钟时为 -7.9,95%置信区间 -15.3至 -0.6,p = 0.035;30分钟时为 -10.6,95%置信区间 -18.6至 -2.6,p = 0.010)。在需要急救药物的患者数量方面,各治疗组之间没有显著差异,然而,与安慰剂相比,服用可溶性阿司匹林的患者给药时间明显更长(风险比2.34,95%置信区间1.41至3.88,p < 0.001)。
本研究结果表明,在第三磨牙手术后的早期,900毫克可溶性阿司匹林比1000毫克对乙酰氨基酚提供显著且更快的镇痛效果。