Reinhart D J, Goldberg M E, Roth J V, Dua R, Nevo I, Klein K W, Torjman M, Vekeman D
Department of Anesthesiology, University of Utah, USA.
Can J Anaesth. 1997 Apr;44(4):377-84. doi: 10.1007/BF03014457.
To assess the safety and efficacy of transdermal fentanyl plus im ketorolac vs im ketorolac alone in the treatment of postoperative pain.
Ninety-two patients scheduled for surgery involving moderate to severe postoperative pain were randomized to one of two groups. Group A (n = 46) received an active fentanyl patch and group P (n = 46) received a placebo patch. Patches remained in place for 24 hr. Each patient received intraoperative ketorolac, 60 mg im. Patients were monitored for 36 hr postoperatively and the groups were analyzed for ketorolac usage, pain scores, vital signs, serum fentanyl concentrations, and adverse events. Intramuscular ketorolac was available on demand.
Group A had lower pain scores at 8.12, 16 and 24 hr after patch placement (P < 0.05). Group A had lower heart rates, lower respiratory rates and fewer dropouts due to inadequate pain relief (4.3% vs 21.7% P < 0.05). Group A patients also used less ketorolac than group P patients (P < 0.05). The incidence of pruritus was higher in group A patients (19% vs 2%, P < 0.05), while the incidence of nausea and vomiting was not different between the two groups. Transdermal fentanyl was adequate "stand-alone" analgesia in only 23.8% of group A patients while 93.7% of the remaining group A patients receiving a combination of transdermal fentanyl and ketorolac had adequate pain relief.
The transdermal fentanyl delivery system plus ketorolac im was more effective in controlling post-operative pain than ketorolac im alone. The two treatment modalities were comparable in safety with no difference in serious adverse events.
评估透皮芬太尼联合酮咯酸肌注与单纯酮咯酸肌注治疗术后疼痛的安全性和有效性。
92例计划接受术后中重度疼痛手术的患者被随机分为两组。A组（n = 46）接受活性芬太尼贴剂，P组（n = 46）接受安慰剂贴剂。贴剂保留24小时。每位患者术中接受60mg酮咯酸肌注。术后对患者进行36小时监测，并分析两组的酮咯酸使用情况、疼痛评分、生命体征、血清芬太尼浓度和不良事件。必要时可肌注酮咯酸。
A组在贴剂放置后8、12、16和24小时的疼痛评分较低（P < 0.05）。A组心率较低、呼吸频率较低，因疼痛缓解不足导致的退出率较低（4.3%对21.7%，P < 0.05）。A组患者使用的酮咯酸也比P组患者少（P < 0.05）。A组患者瘙痒发生率较高（19%对2%，P < 0.05），而两组恶心和呕吐发生率无差异。仅23.8%的A组患者透皮芬太尼是充分的“单一”镇痛方法，而其余接受透皮芬太尼和酮咯酸联合治疗的A组患者中，93.7%疼痛得到充分缓解。
透皮芬太尼给药系统联合酮咯酸肌注在控制术后疼痛方面比单纯酮咯酸肌注更有效。两种治疗方式在安全性方面具有可比性，严重不良事件无差异。
