Division of Rhinology and Endoscopic Skull Base Surgery, Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California.
Division of Rhinology and Endoscopic Skull Base Surgery, Department of Otorhinolaryngology, Mayo Clinic, Rochester, Minnesota.
JAMA Otolaryngol Head Neck Surg. 2021 Sep 1;147(9):811-819. doi: 10.1001/jamaoto.2021.1839.
The opioid epidemic has generated interest in optimizing opioid prescribing after common surgeries. Recent studies have shown a broad range of analgesic prescription patterns following endoscopic sinus surgery (ESS).
To compare the efficacy of different analgesic regimens after ESS.
DESIGN, SETTING, AND PARTICIPANTS: This multi-institutional, nonblinded randomized clinical trial was conducted at 6 tertiary centers across the US and Canada and included participants who underwent ESS for acute or chronic rhinosinusitis. The study was conducted from March 2019 to March 2020, and the data were analyzed in November to December 2020.
All participants received acetaminophen, 650 mg, as the first-line analgesic. From there, patients were randomized to either oxycodone rescue (oxycodone, 5 mg, as second-line therapy) or ibuprofen rescue (ibuprofen, 600 mg, as second-line therapy, with oxycodone, 5 mg, reserved for breakthrough pain).
Baseline characteristics and disease severity were collected at enrollment. Medication logs, pain scores, and epistaxis measures were collected until postoperative day 7. The primary outcome was the postoperative visual analog scale score for pain. Brief Pain Inventory Pain Severity and Pain Interference Scores were also collected.
A total of 118 patients were randomized (62 [52.5%] oxycodone rescue, 56 [47.5%] ibuprofen rescue; mean [SD] age, 46.7 [16.3] years; 44 women [44.0%]; 83 White [83.0%], 7 Black [7.0%], and 7 Asian individuals [7.0%]). After exclusions for loss to follow-up and noncompliance, 51 remained in the oxycodone rescue group and 49 in the ibuprofen rescue group. The groups had similar demographic characteristics and disease severity. Thirty-two (63%) in the oxycodone rescue group had adequate pain management with acetaminophen only, while 19 (37%) consumed at least 1 oxycodone dose. In the ibuprofen rescue group, 18 (16%) required only acetaminophen, 28 (57%) used only acetaminophen and ibuprofen, and the remaining 13 (26%) consumed 1 or more oxycodone doses. The groups had similar average acetaminophen (9.69 vs 7.96 doses; difference, 1.73; 95% CI, -1.37 to 4.83) and oxycodone (1.89 vs 0.77 doses; difference, 1.13; 95% CI, -0.11 to 2.36) use. Both groups had similar postoperative visual analog scale scores. A subanalysis that compared opioids users with nonusers showed clinically significant lower pain scores in nonusers at multiple postoperative points.
In this randomized clinical trial, most patients who underwent ESS could be treated postoperatively using a nonopioid regimen of either acetaminophen alone or acetaminophen and ibuprofen. Ibuprofen as a second-line therapy did not reduce overall narcotic consumption, but the overall narcotic use was low in both groups.
ClinicalTrials.gov Identifier: NCT03783702.
阿片类药物泛滥促使人们关注常见手术后阿片类药物的合理使用。最近的研究表明，内镜鼻窦手术（ESS）后存在广泛的镇痛药物处方模式。
比较 ESS 后不同镇痛方案的疗效。
设计、地点和参与者：这是一项多机构、非盲随机临床试验，在美国和加拿大的 6 个三级中心进行，纳入了因急性或慢性鼻-鼻窦炎而行 ESS 的患者。研究于 2019 年 3 月至 2020 年 3 月进行，数据于 2020 年 11 月至 12 月进行分析。
所有患者均接受扑热息痛（扑热息痛，650 mg）作为一线镇痛药。在此基础上，患者被随机分为羟考酮解救组（羟考酮，5 mg，作为二线治疗）或布洛芬解救组（布洛芬，600 mg，作为二线治疗，备用羟考酮，5 mg，用于缓解突破性疼痛）。
在入组时收集基线特征和疾病严重程度。术后第 7 天收集用药记录、疼痛评分和鼻出血情况。主要结局是术后视觉模拟评分法（VAS）疼痛评分。还收集了简明疼痛量表（BPI）疼痛严重程度和疼痛干扰评分。
共随机分配 118 例患者（羟考酮解救组 62 例[52.5%]，布洛芬解救组 56 例[47.5%]；平均[标准差]年龄为 46.7[16.3]岁；44 例女性[44.0%]；83 例白人[83.0%]，7 例黑人[7.0%]，7 例亚洲人[7.0%]）。排除失访和不依从后，羟考酮解救组 51 例，布洛芬解救组 49 例。两组具有相似的人口统计学特征和疾病严重程度。32 例（63%）羟考酮解救组仅用扑热息痛即可进行充分的疼痛管理，19 例（37%）至少服用 1 次羟考酮。在布洛芬解救组中，18 例（16%）仅需扑热息痛，28 例（57%）仅使用扑热息痛和布洛芬，其余 13 例（26%）服用 1 次或多次羟考酮。两组患者使用扑热息痛的平均剂量相似（9.69 次与 7.96 次；差值，1.73；95%置信区间，-1.37 至 4.83），羟考酮（1.89 次与 0.77 次；差值，1.13；95%置信区间，-0.11 至 2.36）。两组患者术后 VAS 评分相似。一项对阿片类药物使用者和非使用者的亚组分析显示，在多个术后时间点，非使用者的疼痛评分明显较低。
在这项随机临床试验中，大多数接受 ESS 的患者可以使用非阿片类药物方案进行术后治疗，即单独使用扑热息痛或扑热息痛联合布洛芬。布洛芬作为二线治疗并不能减少整体阿片类药物的使用，但两组的整体阿片类药物使用量都较低。
ClinicalTrials.gov 标识符：NCT03783702。
