Faculty of Medicine, Celal Bayar University, Faculty of Medicine, Manisa, Turkey.
Braz J Med Biol Res. 2010 Aug;43(8):806-11. doi: 10.1590/s0100-879x2010007500063. Epub 2010 Jul 9.
The preemptive analgesic efficacy and adverse effects of preoperatively administered piroxicam-beta-cyclodextrin for post-endoscopic sinus surgery pain was determined in a prospective, double-blind, randomized, clinical study. Seventy-five American Society of Anesthesiologists status I-II patients, aged 18-65 years, were divided into three groups with similar demographic characteristics: group 1 received 20 mg piroxicam-beta-cyclodextrin, group 2 received 40 mg piroxicam-beta-cyclodextrin and group 3 received placebo orally before induction of general anesthesia. A blinded observer recorded the incidence and severity of pain at admission to the post-anesthesia care unit (PACU), at 15, 30, and 45 min in the PACU, and 1, 2, 4, 6, and 24 h postoperatively. All patients received patient-controlled morphine analgesia during the postoperative period and consumption was recorded for 24 h. During the PACU period, mean visual analogue scale values were significantly lower in groups 1 and 2 compared to group 3 (P < 0.05). During the postoperative period, morphine consumption was 3.03 +/- 2.54, 2.7 +/- 2.8, and 5.56 +/- 3.12 mg for each group, respectively (P < 0.05). As a side effect, bleeding was observed in groups 1 and 3, nausea and vomiting in all groups, and edema only in group 3. However, no significant differences were detected in any of the parameters analyzed, which also included epigastric pain, constipation/diarrhea and headache. Similar hematological test results were obtained for all groups. Preemptive administration of piroxicam-beta-cyclodextrin effectively reduced analgesic consumption, and 40 mg of the drug was more effective than 20 mg piroxicam-beta-cyclodextrin without side effects during the postoperative period.
一项前瞻性、双盲、随机、临床试验旨在确定术前给予吡罗昔康-β-环糊精对内镜鼻窦手术后疼痛的预防性镇痛效果和不良反应。75 名美国麻醉医师协会（ASA）I-II 级的患者，年龄 18-65 岁，分为三组，具有相似的人口统计学特征：组 1 口服 20mg 吡罗昔康-β-环糊精，组 2 口服 40mg 吡罗昔康-β-环糊精，组 3 口服安慰剂。一位盲法观察者记录患者进入麻醉后监护病房（PACU）时、PACU 内 15、30 和 45 分钟时、术后 1、2、4、6 和 24 小时时疼痛的发生率和严重程度。所有患者在术后期间均接受患者自控吗啡镇痛，记录 24 小时的用量。PACU 期间，组 1 和 2 的平均视觉模拟评分显著低于组 3（P < 0.05）。术后期间，各组吗啡用量分别为 3.03 +/- 2.54、2.7 +/- 2.8 和 5.56 +/- 3.12mg（P < 0.05）。作为副作用，组 1 和 3 出现出血，所有组出现恶心和呕吐，仅组 3 出现水肿。然而，在分析的所有参数中，包括上腹痛、便秘/腹泻和头痛，均未检测到显著差异。所有组的血液学检查结果相似。预防性给予吡罗昔康-β-环糊精可有效减少镇痛药物的使用，且在术后期间，40mg 药物比 20mg 吡罗昔康-β-环糊精更有效，且无副作用。
