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静脉注射酮咯酸氨丁三醇与硫酸吗啡治疗术后即刻疼痛的对比研究

Intravenous ketorolac tromethamine versus morphine sulfate in the treatment of immediate postoperative pain.

作者信息

Peirce R J, Fragen R J, Pemberton D M

机构信息

Department of Anesthesia, Northwestern University Medical School, Chicago, Illinois 60611.

出版信息

Pharmacotherapy. 1990;10(6 ( Pt 2)):111S-115S.

PMID:2082306
Abstract

Intravenous ketorolac tromethamine was compared with morphine sulfate for the relief of moderate to severe postoperative pain and for side effects in 125 women undergoing major abdominal gynecologic surgery. Patients were randomly assigned to receive an initial intravenous dose of ketorolac 10 mg, ketorolac 30 mg, morphine 2 mg, or morphine 4 mg, administered in a double-blind fashion. No other narcotics were administered in the 3 hours preceding the first dose of study drug. A second dose was administered on request, but no sooner than 15 minutes after the initial dose. Patients who required additional analgesia within the 6-hour observation period were remedicated with a backup analgesic and withdrawn from the study. Pain scores and side effect evaluations were performed at baseline, 30 minutes, 1 hour, and then hourly for up to 6 hours or until the subject terminated the study. No significant differences among the treatments were noted in terms of area under the time-effect curves for pain intensity differences or pain relief. In each treatment group, 70-80% of patients withdrew within 1 hour and approximately 90% within 3 hours of the initial drug dose because of inadequate analgesia. With the dosage regimens used, neither drug adequately controlled moderate to severe pain in the immediate postoperative period. Patients receiving ketorolac experienced significantly less drowsiness than those given morphine, and some subjects in each experienced nausea. No serious adverse effects were reported.

摘要

将静脉注射酮咯酸氨丁三醇与硫酸吗啡用于缓解125例行大型妇科腹部手术女性的中度至重度术后疼痛及副作用进行比较。患者被随机分配接受初始静脉注射剂量的10毫克酮咯酸、30毫克酮咯酸、2毫克吗啡或4毫克吗啡,采用双盲方式给药。在首次给予研究药物前3小时内未使用其他麻醉剂。根据需要给予第二剂,但不早于初始剂量后15分钟。在6小时观察期内需要额外镇痛的患者用备用镇痛药再次给药并退出研究。在基线、30分钟、1小时,然后每小时进行疼痛评分和副作用评估,直至6小时或直至受试者终止研究。在疼痛强度差异或疼痛缓解的时间效应曲线下面积方面,各治疗组之间未观察到显著差异。在每个治疗组中,70 - 80%的患者在初始药物剂量后1小时内退出,约90%在3小时内退出,原因是镇痛不足。在所使用的给药方案下,两种药物在术后即刻均未充分控制中度至重度疼痛。接受酮咯酸的患者比接受吗啡的患者嗜睡明显更少,且每组中一些受试者出现恶心。未报告严重不良反应。

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