Chen Fang, Wang Cheng-Yu, Zhang Jianmin, Wang Fang, Zhang Mazhong, Gu Hongbin, Song Xingrong, Chen Jia, Li Yang, Cai Yu-Hang, Li Jun, Lian Qing-Quan, Wu Junzheng, Liu Hua-Cheng
Key Laboratory of Anesthesiology of Zhejiang Province, Department of Anesthesiology, Perioperative and Pain Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Zhejiang, China.
Department of Anesthesiology, Beijing Children's Hospital, Capital Medical University, Beijing, China.
Front Pharmacol. 2020 Dec 9;11:597550. doi: 10.3389/fphar.2020.597550. eCollection 2020.
There is no universal agreement on optimal pharmacological regimens for pain management during surgeries. The aim of this study to compare the postoperative analgesic effects of nalbuphine with fentanyl in children undergoing adenotonsillectomy. We conducted a prospective, randomized, double-blind, non-inferiority and multicenter trial in 311 patients admitted to four different medical facilities in China from October 2017 to November 2018. The primary outcome was postoperative pain score. The secondary outcomes were as follows: the numbers of patients who developed moderate or severe pain (FLACC ≥4 points); time to first rescue analgesic top up and the actual number of rescue pain medicine given in pain control in post-anesthesia care unit (PACU), and additional analgesics requirement (received ≥2 rescue analgesics or/and other analgesics except study medications administered in PACU and ward); emergence and extubation time; Waking up time; time of PACU stay, and other side effects (desaturation, nausea/vomiting etc.). A total of 356 children were screened and 322 patients were randomized. The mean age was 5.8 (5.5, 6.1) in the nalbuphine group and 5.6 (5.3, 5.8) in the fentanyl group ( = 0.2132). FLACC score of nalbuphine group was lower than that of fentanyl group upon patients' arrival at PACU ( < 0.05). The time to first required rescue dose of pain drug for nalbuphine group was longer than for the fentanyl group (2.5 vs 1.2 h, < 0.0001). Only one patient (0.6%) in nalbuphine group presented a slow respiratory rate (RR) at 9/min while 29 patients (18.5%) in fentanyl group developed slow RR ≤10/min in PACU. Meanwhile, SpO was lower in the fentanyl group at 10 min after patients' arrival in PACU ( < 0.05). The other profiles observed from these two drug groups were similar. Nalbuphine provided better pain relief with minimal respiration depression than fentanyl in children undergoing Adenotonsillectomy.
对于手术期间疼痛管理的最佳药物治疗方案，目前尚无普遍共识。本研究旨在比较纳布啡与芬太尼在接受腺样体扁桃体切除术儿童中的术后镇痛效果。2017年10月至2018年11月，我们在中国四家不同医疗机构收治的311例患者中进行了一项前瞻性、随机、双盲、非劣效性多中心试验。主要结局是术后疼痛评分。次要结局如下：出现中度或重度疼痛（面部表情、腿活动、活动、哭闹、安慰评分法[FLACC]≥4分）的患者数量；首次追加抢救镇痛药的时间以及麻醉后监护病房（PACU）疼痛控制中实际给予的抢救镇痛药数量，以及额外镇痛药需求（接受≥2次抢救镇痛药或/和除PACU和病房给予的研究药物外的其他镇痛药）；苏醒和拔管时间；清醒时间；PACU停留时间，以及其他副作用（血氧饱和度下降、恶心/呕吐等）。共筛查了356名儿童，322例患者被随机分组。纳布啡组的平均年龄为5.8（5.5，6.1）岁，芬太尼组为5.6（5.3，5.8）岁（P = 0.2132）。患者到达PACU时，纳布啡组的FLACC评分低于芬太尼组（P < 0.05）。纳布啡组首次需要使用镇痛药物抢救剂量的时间比芬太尼组长（2.5小时对1.2小时，P < 0.0001）。纳布啡组只有1例患者（0.6%）在PACU出现呼吸频率（RR）减慢至9次/分钟，而芬太尼组有29例患者（18.5%）在PACU出现RR减慢≤10次/分钟。同时，患者到达PACU后10分钟时，芬太尼组的血氧饱和度较低（P < 0.05）。从这两个药物组观察到的其他情况相似。在接受腺样体扁桃体切除术的儿童中，与芬太尼相比，纳布啡能提供更好的疼痛缓解且呼吸抑制最小。
