Sutters Kimberly A, Miaskowski Christine, Holdridge-Zeuner Danielle, Waite Steven, Paul Steven M, Savedra Marilyn C, Lanier Brent
Children's Hospital Central California, Madera 93638-8762, USA.
Pain Manag Nurs. 2005 Jun;6(2):49-57. doi: 10.1016/j.pmn.2005.01.001.
As part of a randomized clinical trial that compared three different analgesic dosing regimens ( Sutters et al., 2004 ), the purpose of this study, in children who underwent tonsillectomy, was to determine whether around-the-clock (ATC) dosing of acetaminophen with codeine, compared with as-needed (PRN) dosing, increased the frequency of moderate-to-severe opioid-related side effects (i.e., daytime sedation, lightheadedness, nightmares, nausea, vomiting, and constipation) in the first 3 days after surgery. Because no differences were found in pain intensity scores and in the amount of analgesic administered between the two ATC groups (i.e., with and without coaching), for these analyses, the two groups were combined ( n = 52) and compared with the PRN group ( n = 28). Each side effect was recoded into a dichotomous response (i.e., 0 = did not have symptoms or had slight symptoms; 1 = symptoms that were moderate, severe, or very severe) to provide an adequate sample size in each cell for the statistical analyses. No differences were found in the frequency of moderate-to-severe side effects between the ATC and PRN groups at any of the postoperative assessments. The number of children who reported moderate-to-severe daytime sedation decreased over time in both the PRN ( p = .02) and ATC groups ( p = .01). Children in the ATC groups reported a statistically significant decrease over time in vomiting ( p = .001) and feeling lightheaded or dizzy ( p = .003), and a significant increase in constipation ( p = .018). Except for daytime sedation, changes, over time, in the frequency of moderate-to-severe side effects were not observed in the PRN group.
作为一项比较三种不同镇痛给药方案的随机临床试验的一部分（萨特斯等人，2004年），本研究的目的是，在接受扁桃体切除术的儿童中，确定与按需（PRN）给药相比，对乙酰氨基酚与可待因的全天候（ATC）给药是否会增加术后前3天中度至重度阿片类药物相关副作用（即日间镇静、头晕、噩梦、恶心、呕吐和便秘）的发生率。由于在两个ATC组（即有和没有指导）之间，疼痛强度评分和给予的镇痛药物量均未发现差异，因此在这些分析中，将这两个组合并（n = 52）并与PRN组（n = 28）进行比较。每种副作用都被重新编码为二分反应（即0 = 没有症状或有轻微症状；1 = 中度、重度或非常严重的症状），以便为每个单元格提供足够的样本量进行统计分析。在任何术后评估中，ATC组和PRN组之间中度至重度副作用的发生率均未发现差异。报告有中度至重度日间镇静的儿童数量在PRN组（p = .02）和ATC组（p = .01）中均随时间减少。ATC组的儿童报告呕吐（p = .001）和感到头晕或眩晕（p = .003）随时间有统计学显著下降，便秘有显著增加（p = .018）。除日间镇静外，PRN组未观察到中度至重度副作用发生率随时间的变化。
