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术前静脉给予美洛昔康治疗术后即刻中重度疼痛:一项在 55 例行开放性或腹腔镜结直肠手术伴肠切除和/或吻合术的患者中开展的 IIIb 期随机临床试验。

Preoperative intravenous meloxicam for moderate-to-severe pain in the immediate post-operative period: a Phase IIIb randomized clinical trial in 55 patients undergoing primary open or laparoscopic colorectal surgery with bowel resection and/or anastomosis.

机构信息

Department of Surgery, Tulane University, New Orleans, LA, 70112, USA.

Department of Surgery, Tampa General Hospital, Tampa, FL, 33606, USA.

出版信息

Pain Manag. 2021 Jan;11(1):9-21. doi: 10.2217/pmt-2020-0061. Epub 2020 Oct 23.

Abstract

Evaluate safety/efficacy of intravenous meloxicam in a colorectal enhanced recovery after surgery protocol. Adults undergoing primary open or laparoscopic colorectal surgery with bowel resection and/or anastomosis received meloxicam IV 30 mg (n = 27) or placebo (n = 28) once daily beginning 30 min before surgery. Adverse events: meloxicam IV, 85%; placebo, 93%. Adverse events commonly associated with opioids: 41 versus 61% - including nausea (33 vs 50%), vomiting (19 vs 18%) and ileus (4 vs 18%). Wound healing satisfaction scores (physician-rated), clinical laboratory findings and vital signs were similar in both groups. No anastomotic leaks were reported. Opioid consumption, postoperative pain intensity, length of stay and times to first bowel sound, first flatus and first bowel movement were significantly lower with meloxicam IV versus placebo. Most subjects (>92%) were satisfied with postoperative pain medication. Meloxicam IV was generally well tolerated and associated with decreased opioid consumption, lower resource utilization and functional benefits. NCT03323385 (ClinicalTrials.gov).

摘要

评估静脉用美洛昔康在结直肠手术后恢复增强方案中的安全性/疗效。 接受原发性开放性或腹腔镜结直肠手术、肠切除和/或吻合术的成年人在手术前 30 分钟开始每天接受一次静脉用美洛昔康 30mg(n=27)或安慰剂(n=28)。 不良事件:静脉用美洛昔康,85%;安慰剂,93%。与阿片类药物常见相关的不良事件:41%对 61%-包括恶心(33%对 50%)、呕吐(19%对 18%)和肠梗阻(4%对 18%)。两组的伤口愈合满意度评分(医生评估)、临床实验室检查结果和生命体征相似。未报告吻合口漏。与安慰剂相比,静脉用美洛昔康的阿片类药物消耗、术后疼痛强度、住院时间以及首次肠鸣音、首次排气和首次排便时间均显著降低。大多数受试者(>92%)对术后疼痛药物满意。 静脉用美洛昔康通常耐受良好,与阿片类药物消耗减少、资源利用降低和功能获益相关。NCT03323385(ClinicalTrials.gov)。

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