Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.
Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.
Am J Emerg Med. 2021 Aug;46:579-584. doi: 10.1016/j.ajem.2020.11.034. Epub 2020 Nov 20.
Previous research demonstrated that administration of Morphine Sulfate Immediate Release (MSIR) results in similar analgesic efficacy to Oxycodone but with significantly lesser degrees of euphoria and reward. The purpose of this study sit to investigate if MSIR combined with Acetaminophen can serve as an opioid analgesic alternative to Oxycodone combined with acetaminophen (Percocet) for acute pain in the Emergency Department (ED).
A prospective, randomized, double-blind trial of ED patients aged 18 to 64 years presenting with moderate to severe acute pain as defined by an 11-point numeric rating scale (NRS) with an initial score of ≥5 (0 = no pain and 10 = very severe pain). Patients were randomized to receive either 15 mg MSIR combined with 650 mg of Acetaminophen or 10 mg Oxycodone combined with 650 mg Acetaminophen. Patients were assessed at baseline, 30, 45 and 60 min. The primary outcome was reduction in pain at 60 min. Secondary outcomes include drug likeability and adverse events.
80 patients were enrolled in the study (40 per group). Demographic characteristics were similar between the groups (P > 0.05). Mean NRS pain scores at baseline were 8.44 for the MSIR group and 8.53 for the Percocet group (P = 0.788). Mean pain scores decreased over time but remained similar between the groups: 30 min (6.03 vs. 6.43; P = 0.453), 45 min (5.31 vs. 5.48; P = 0.779), and 60 min (4.22 vs. 4.87; P = 0.346). Reduction in mean NRS pain scores were statistically significant from baseline to 30, 45 and 60 min within each group (P < 0.0001 at each time point for both groups). The largest NRS mean difference was from baseline to 60 min: 4.2 (95% CI: 3.43 to 5.01) for MSIR group and 3.61 (95% CI: 2.79 to 4.43) for Percocet group. No clinically significant changes or any serious adverse events were observed in either group.
MSIR provides similar analgesic efficacy as Percocet for short-term pain relief in the ED, similar rates of nausea/vomiting, and lower rates of likeability of the drug.
先前的研究表明,硫酸吗啡即时释放(MSIR)的给药与羟考酮具有相似的镇痛效果,但欣快感和奖赏的程度明显较低。本研究旨在探讨 MSIR 联合对乙酰氨基酚是否可以替代羟考酮联合对乙酰氨基酚(派替啶)作为急诊科(ED)急性疼痛的阿片类镇痛药。
对年龄在 18 至 64 岁之间的 ED 患者进行前瞻性、随机、双盲试验,这些患者的中度至重度急性疼痛由 11 点数字评分量表(NRS)定义,初始评分≥5(0=无痛,10=非常严重疼痛)。患者被随机分为接受 15mg MSIR 联合 650mg 对乙酰氨基酚或 10mg 羟考酮联合 650mg 对乙酰氨基酚。患者在基线、30、45 和 60 分钟时进行评估。主要结局是 60 分钟时疼痛的缓解。次要结局包括药物的可接受性和不良事件。
共有 80 名患者入组本研究(每组 40 名)。两组的人口统计学特征相似(P>0.05)。MSIR 组和派替啶组的基线 NRS 疼痛评分均为 8.44(P=0.788)。随着时间的推移,平均 NRS 疼痛评分下降,但两组之间仍相似:30 分钟(6.03 对 6.43;P=0.453)、45 分钟(5.31 对 5.48;P=0.779)和 60 分钟(4.22 对 4.87;P=0.346)。两组中,与基线相比,NRS 疼痛评分在 30、45 和 60 分钟时均有统计学显著降低(每组在每个时间点均<0.0001)。NRS 平均差值最大的是从基线到 60 分钟:MSIR 组为 4.2(95%CI:3.43 至 5.01),派替啶组为 3.61(95%CI:2.79 至 4.43)。两组均未观察到临床显著变化或任何严重不良事件。
MSIR 与派替啶相比,在 ED 中短期缓解疼痛具有相似的镇痛效果、相似的恶心/呕吐发生率和较低的药物可接受性。