Christensen Kyle S, Cohen Amy E, Mermelstein Fred H, Hamilton Douglas A, McNicol Ewan, Babul Najib, Carr Daniel B
Jean Brown Associates, Salt Lake City, Utah, USA.
Anesth Analg. 2008 Dec;107(6):2018-24. doi: 10.1213/ane.0b013e318187b952.
Opioids are standard treatment for postoperative pain. In this study, we compared the safety and efficacy of intranasal (i.n.) morphine to i.v. and oral morphine and placebo.
Two-hundred-twenty-five patients with moderate-to-severe pain after third molar extraction were randomized to receive a single dose of i.n. morphine 7.5 mg or 15 mg, i.v. morphine 7.5 mg, oral morphine 60 mg or placebo. Pain intensity was assessed using visual analog and categorical scales, and pain relief using a categorical scale. Outcomes included total pain relief, pain intensity difference, summed pain intensity difference, time to analgesic onset, time to requesting rescue medication, and patients' global evaluation of their treatment. Safety assessments included adverse event recording and nasal examinations.
Across the various efficacy outcomes, both i.n. morphine doses were statistically similar to the positive comparators (i.v. and oral morphine), and all four morphine treatments were statistically superior to placebo. Overall, i.n. morphine 15 mg presented an efficacy profile similar to i.v. morphine 7.5 mg; both treatments demonstrated rapid onset of efficacy, generally persistent throughout the 6-h assessment period. The lower dose of i.n. morphine, 7.5 mg, was statistically similar to the other active treatments at 2 h and 6 h and similar to placebo at 4 h. Study medications were generally well tolerated, with no withdrawals due to adverse events or other safety concerns, and no serious adverse events reported. The most frequently reported adverse events were typical systemic opioid effects.
I.n. morphine offers a noninvasive alternative to i.v. morphine for postoperative analgesia.
阿片类药物是术后疼痛的标准治疗方法。在本研究中，我们比较了鼻内（i.n.）吗啡与静脉注射（i.v.）和口服吗啡及安慰剂的安全性和有效性。
225例拔除第三磨牙后出现中重度疼痛的患者被随机分为接受单剂量7.5mg或15mg的鼻内吗啡、7.5mg静脉注射吗啡、60mg口服吗啡或安慰剂。使用视觉模拟量表和分类量表评估疼痛强度，使用分类量表评估疼痛缓解情况。结果包括总疼痛缓解、疼痛强度差异、累计疼痛强度差异、镇痛起效时间、请求救援药物的时间以及患者对其治疗的总体评价。安全性评估包括不良事件记录和鼻腔检查。
在各种疗效结果方面，两种鼻内吗啡剂量在统计学上与阳性对照（静脉注射和口服吗啡）相似，并且所有四种吗啡治疗在统计学上均优于安慰剂。总体而言，15mg鼻内吗啡的疗效与7.5mg静脉注射吗啡相似；两种治疗均显示起效迅速，在整个6小时评估期内通常持续有效。较低剂量的7.5mg鼻内吗啡在2小时和6小时时在统计学上与其他活性治疗相似，在4小时时与安慰剂相似。研究药物总体耐受性良好，没有因不良事件或其他安全问题而停药，也没有严重不良事件报告。最常报告的不良事件是典型的全身性阿片类药物效应。
鼻内吗啡为术后镇痛提供了一种非侵入性的静脉注射吗啡替代方法。
