Moodie John E, Brown Colin R, Bisley Eileen J, Weber Hans U, Bynum Lincoln
Waikato Clinical Research, Department of Anaesthesia, Health Waikato, Hamilton, New Zealand.
Anesth Analg. 2008 Dec;107(6):2025-31. doi: 10.1213/ane.0b013e318188b736.
We evaluated the safety and efficacy of multiple doses of intranasal ketorolac tromethamine (ketorolac) for postoperative pain.
This was a double-blind, placebo-controlled study in patients undergoing major surgery who were randomized to receive intranasal ketorolac, 10 mg or 31.5 mg, [DOSAGE ERROR CORRECTED]or placebo every 8 h for 40 h. After surgery, patients with pain intensity of at least 40 on a 100-mm visual analog scale were assessed at 30 min and at 1, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 h after receiving the study drug. Patient-controlled i.v. morphine provided supplemental analgesia.
Among 127 patients enrolled, morphine use during the first 24 h was significantly less in patients receiving 31.5 mg [DOSAGE ERROR CORRECTED] of ketorolac (37.8 mg) than in the placebo group (56.5 mg) and in the 10-mg ketorolac group (54.3 mg). Over 48 h, the 31.5-mg ketorolac [DOSAGE ERROR CORRECTED] group used significantly less morphine than the placebo group. Summed pain intensity differences at 4 and 6 h significantly favored the 31.5-mg ketorolac [DOSAGE ERROR CORRECTED]group over the other groups. The rates of pyrexia and tachycardia were significantly lower in the ketorolac 31.5-mg [DOSAGE ERROR CORRECTED]group than in the placebo group. Other adverse events were reported with similar frequency in all treatment groups and most were considered unrelated to treatment.
Thirty milligrams of intranasal ketorolac demonstrated significant analgesic efficacy compared to 10 mg of intranasal ketorolac and placebo.
我们评估了多次剂量的鼻内注射酮咯酸氨丁三醇（酮咯酸）用于术后疼痛的安全性和有效性。
这是一项双盲、安慰剂对照研究，研究对象为接受大手术的患者，这些患者被随机分为每8小时接受10毫克或31.5毫克（剂量已校正）的鼻内酮咯酸、或安慰剂，共持续40小时。术后，对于视觉模拟评分至少为40分（满分100分）的疼痛患者，在接受研究药物后的30分钟以及1、2、3、4、5、6、8、12、16、20、24、28、32、36、40、44和48小时进行评估。患者自控静脉注射吗啡提供补充镇痛。
在127名入组患者中，接受31.5毫克（剂量已校正）酮咯酸的患者在前24小时内的吗啡使用量（37.8毫克）显著低于安慰剂组（56.5毫克）和10毫克酮咯酸组（54.3毫克）。在48小时内，31.5毫克酮咯酸（剂量已校正）组使用的吗啡显著少于安慰剂组。在4小时和6小时时，累积疼痛强度差异显著有利于31.5毫克酮咯酸（剂量已校正）组，超过其他组。31.5毫克（剂量已校正）酮咯酸组的发热和心动过速发生率显著低于安慰剂组。所有治疗组报告的其他不良事件频率相似，且大多数被认为与治疗无关。
与10毫克鼻内酮咯酸和安慰剂相比，30毫克鼻内酮咯酸显示出显著的镇痛效果。
