, Hägersten, Sweden.
Department of Clinical Science, Intervention and Technology, CLINTEC, Karolinska Institutet, Stockholm, Sweden.
Eur Arch Otorhinolaryngol. 2019 Nov;276(11):3231-3238. doi: 10.1007/s00405-019-05571-w. Epub 2019 Aug 3.
Our previous randomized controlled trial (RCT) of children with obstructive sleep apnea (OSA) showed no significant differences between adenotonsillectomy (ATE) and adenotonsillomy (ATE) in improving nocturnal respiration and symptoms after one year. This is the continuous report with the evaluation of postoperative morbidity concerning bleeding and pain.
A double-blinded RCT including 79 children, aged 2-6 years, with moderate to severe OSA, randomized to either ATE (n = 40) or ATT (n = 39). From one to ten days postoperatively, parents filled in a logbook with six pain-related outcomes (parent and child grading pain at different levels, days of analgesic use and return to normal diet). Peri- and postoperative bleeding were also registered.
63 patients (80%) returned the logbook. There were significant differences between groups in only two of the six pain-related outcomes in favor of the ATT group; first day when the children graded themselves as pain free (p = 0.021, Log Rank Test), and first day the caregiver estimated pain VAS ≤ 5 (p = 0.007, Log Rank Test). Two (5%) cases of postoperative bleeding occurred in the ATE group, one of which needed a return to theatre. No case of postoperative bleeding was seen in the ATT group.
The results from this RCT are in line with previous comparative studies between ATT and ATE. Children operated with ATT had significantly less postoperative pain in one-third of the outcomes, and less bleeding than ATE. However, as the differences in morbidity between the surgical methods were minor the clinical significance is uncertain.
This study was approved by the Swedish Regional Ethics Board in Stockholm, Sweden (Dnr 2011/925-32 and 2013/2274-32) and registered at ClinicalTrials.gov (Trial registration number NCT01676181).
我们之前对患有阻塞性睡眠呼吸暂停（OSA）的儿童进行的随机对照试验（RCT）显示，腺样体切除术（ATE）和腺样体扁桃体切除术（ATT）在改善一年后夜间呼吸和症状方面没有显著差异。这是对术后出血和疼痛相关发病率进行评估的连续报告。
这项双盲 RCT 纳入了 79 名 2-6 岁、中重度 OSA 的儿童，随机分为 ATE 组（n=40）或 ATT 组（n=39）。术后 1-10 天，父母填写了一份日志，记录了 6 项与疼痛相关的结果（父母和孩子对不同程度的疼痛进行评分、使用镇痛药物的天数和恢复正常饮食的天数）。还记录了围手术期和术后出血情况。
63 名患者（80%）返回了日志。在仅有的 6 项与疼痛相关的结果中的 2 项中，两组之间存在显著差异，ATT 组的结果更好；第一天，孩子自我评估为无痛（p=0.021，对数秩检验），以及第一天护理人员估计疼痛 VAS≤5（p=0.007，对数秩检验）。ATE 组有 2 例（5%）发生术后出血，其中 1 例需要返回手术室。ATT 组未观察到术后出血。
这项 RCT 的结果与 ATT 和 ATE 之间的先前比较研究一致。接受 ATT 手术的儿童在三分之一的结果中术后疼痛明显减轻，且出血少于 ATE。然而，由于手术方法之间的发病率差异较小，其临床意义尚不确定。
该研究得到了瑞典斯德哥尔摩地区伦理委员会的批准（Dnr 2011/925-32 和 2013/2274-32），并在 ClinicalTrials.gov 注册（试验注册号 NCT01676181）。
