Department of Emergency Medicine, Gut and Liver research center, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.
Department of Emergency Medicine, Orthopedic Research Center, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.
Am J Emerg Med. 2019 Jun;37(6):1025-1032. doi: 10.1016/j.ajem.2018.08.038. Epub 2018 Aug 16.
This study attempted to evaluate the efficacy of ultra-low-dose intravenous (IV) naloxone combined with IV morphine, as compared to IV morphine alone, in terms of reducing pain and morphine-induced side effects in patients with renal colic.
In this double-blind clinical trial, 150 patients aged 34 to 60 years old who presented to the emergency department (ED) with renal colic were randomly allocated to either an intervention group that received ultra-low-dose IV naloxone combined with IV morphine or to a control group that received morphine plus a placebo. The severity of pain, sedation, and nausea were assessed and recorded for all patients at entrance to the ED (T1), then at 20 (T2), 40 (T3), 60 (T4), 120 (T5), and 180 (T6) minutes after starting treatment. The Numeric Rating Scale (NRS) was used for the assessment of pain and nausea intensities, and the Ramsay Sedation Scale (RSS) was used to assess sedation.
A GEE model revealed that patients in the naloxone group had non-significantly reduced pain scores compared to those in the morphine group (coefficient = -0.68; 95% CI: -1.24 to -0.11, Wald X2 (1) = 5.41, p = 0.02). The sedation outcome demonstrated no statistically significant differences at T1 to T4 among patients with renal colic compared to the ones who only received morphine. At T5 and T6, 1.5% vs. 20% and 1.5% vs. 16.9% of subjects from the naloxone group versus the morphine group obtained RSS scores equal to 3, respectively (p = 0.001 and p = 0.004, respectively).
Compared to patients who only received IV morphine, co-treatment of ultra-low-dose naloxone with morphine could not provide better analgesia and sedation/agitation states in renal colic patients.
本研究旨在评估小剂量静脉（IV）纳洛酮联合 IV 吗啡与单独使用 IV 吗啡相比，在减轻肾绞痛患者疼痛和吗啡引起的副作用方面的疗效。
在这项双盲临床试验中，将 150 名年龄在 34 岁至 60 岁之间因肾绞痛到急诊科就诊的患者随机分配到干预组（接受小剂量 IV 纳洛酮联合 IV 吗啡）或对照组（接受吗啡加安慰剂）。所有患者在进入急诊科时（T1）、20 分钟（T2）、40 分钟（T3）、60 分钟（T4）、120 分钟（T5）和 180 分钟（T6）时评估和记录疼痛、镇静和恶心的严重程度。数字评分量表（NRS）用于评估疼痛和恶心强度，Ramsay 镇静评分量表（RSS）用于评估镇静。
广义估计方程模型显示，与吗啡组相比，纳洛酮组患者的疼痛评分显著降低（系数=-0.68；95%置信区间：-1.24 至-0.11，Wald X2（1）=5.41，p=0.02）。镇静结果显示，与仅接受吗啡的患者相比，肾绞痛患者在 T1 至 T4 期间没有统计学上的显著差异。在 T5 和 T6 时，纳洛酮组分别有 1.5%和 1.5%的患者与吗啡组的 20%和 16.9%的患者获得 RSS 评分等于 3（p=0.001 和 p=0.004）。
与仅接受 IV 吗啡的患者相比，小剂量纳洛酮与吗啡联合治疗不能为肾绞痛患者提供更好的镇痛和镇静/激越状态。
