A Prospective Randomized Controlled Trial of Two Different Sedation Sequences for Third Molar Removal in Adults

A Prospective Randomized Controlled Trial of Two Different Sedation Sequences for Third Molar Removal in Adults
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DOI:
10.1016/j.joms.2014.08.033
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发表时间:
2015-02-01
影响因子:
1.9
通讯作者:
Rosenberg, Morton
Rosenberg, Morton
中科院分区:
医学4区
文献类型:
--
作者:
Khader, Ruba;Oreadi, Daniel;Rosenberg, Morton

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目的:在口腔颌面门诊手术中,镇静技术是各种外科手术患者管理的重要组成部分。芬太尼和咪达唑仑是常用的镇静剂,具有不同的作用机制和特定的镇痛或遗忘特性。本研究检查了给药顺序是否会影响患者的疼痛感知或手术生命体征。 材料和方法:在机构审查委员会批准并书面知情同意后,对计划在静脉中度镇静下拔除至少 2 个第三磨牙的患者进行了一项前瞻性、随机、平行组临床试验。患者被随机分配到 2 组中的一组。芬太尼组首先接受芬太尼,然后接受咪达唑仑;第一组接受咪达唑仑治疗,然后接受芬太尼治疗。术后 24 小时使用 Wong-Baker FACES 疼痛量表评估术中疼痛评分的回忆。 Mann-Whitney U 检验用于评估两组之间是否存在统计学显着差异。使用 t 检验检查程序生命体征波动的统计学显着差异。评估患者对手术的满意度并进行组间比较。结果:纳入 66 名患者,其中 1 名未完成研究。术后 24 小时回忆的手术疼痛评分在各组之间没有统计学差异。两组的 Wong-Baker FACES 疼痛量表评分中位数分别为:芬太尼组为 2.0(四分位距,3.1),咪达唑仑组为 1.5(四分位距,2.5)(P = .333)。两组的生命体征从基线到 2 个手术终点的变化没有统计学差异。此外,两组患者对手术的满意度没有统计学差异。结论:在这项研究中,在静脉中度镇静手术期间选择性地使用咪达唑仑或芬太尼并没有导致在拔除第三磨牙后 24 小时时重新收集的手术疼痛评分出现可测量的差异。镇静剂的选择及其给药顺序应根据患者的需要、手术类型和外科医生的偏好进行调整。 (C) 2015年美国口腔颌面外科医师协会
Purpose: In oral and maxillofacial outpatient surgery, sedation techniques are an important component in patient management for a wide variety of surgical procedures. Fentanyl and midazolam are commonly used sedatives with different mechanisms of action and specific analgesic or amnestic properties. This study examined whether the order of their administration would affect a patient's pain perception or procedural vital signs.Materials and Methods: After institutional review board approval and written informed consent, a prospective, randomized, parallel-group clinical trial was conducted in patients who planned to undergo removal of at least 2 third molars under intravenous moderate sedation. Patients were randomly assigned to 1 of 2 groups. The fentanyl-first group received fentanyl and then midazolam; the midazolam-first group received midazolam and then fentanyl. Recollection of the intraoperative pain score was assessed 24 hours after surgery using the Wong-Baker FACES pain scale. The Mann-Whitney U test was used to assess for the presence of a statistically significant difference between the 2 groups. Statistically significant differences in procedural vital sign fluctuations were examined using the t test. Patients' satisfaction with the procedure was assessed and intergroup comparisons were made.Results: Sixty-six patients were enrolled, 1 of whom did not complete the study. Recollected procedural pain scores at 24 hours after surgery were not statistically different between groups. Median scores on the Wong-Baker FACES pain scale for the 2 groups were 2.0 (interquartile range, 3.1) for the fentanyl-first group and 1.5 (interquartile range, 2.5) for the midazolam-first group (P = .333). There was no statistical difference in the change in vital signs from baseline to 2 surgical end points in the 2 groups. In addition, patient satisfaction with the procedure did not statistically differ between the 2 groups.Conclusions: In this study, selective sequencing of midazolam or fentanyl during an intravenous moderate-sedation procedure did not result in a measurable difference of recollected procedural pain scores at 24 hours after third molar extraction. The choice of the sedation agents and the order of their administration should be tailored to the patient's needs, type of surgical procedure, and surgeon preference. (C) 2015 American Association of Oral and Maxillofacial Surgeons