PDF(Pubmed)
Abstract：
UNASSIGNED: To investigate the effects of nalbuphine on emergency agitation (EA), which affects up to 80% of the children following otolaryngology procedures, in children undergoing cochlear implantation.
UNASSIGNED: A prospective double-blinded randomized controlled clinical trial was conducted between November 2020 and October 2022. Eligible children, aged 6 months to 3 years old, were randomly assigned to either 0.1 mg/kg, 0.15 mg/kg, 0.2 mg/kg nalbuphine or 0.9% saline groups. EA was defined by the Pediatric Anesthesia Emergence Delirium (PAED) score ≥10. Extubation time, post-anesthesia care unit (PACU) length of stay, severe EA (PAED ≥ 15), peak PAED score, the Faces, Legs, Activity, Cry, and Consolability (FLACC) scale, Ramsay sedation score, and adverse events were also recorded.
UNASSIGNED: A total of 104 children were enrolled, with 26 children in each group. Nalbuphine significantly reduced the EA occurrence from 73.1% in the saline group to 38.5%, 30.8%, and 26.9% in the 0.1 mg/kg, 0.15 mg/kg, and 0.2 mg/kg nalbuphine groups, respectively (P < 0.001), without affecting the extubation time and PACU length of stay. More children (34.6%) in the 0.9% saline group experienced severe EA. Higher dose nalbuphine (0.15 mg/kg, 0.2 mg/kg) showed lower peak PAED score, better analgesia and sedation effect compared with 0.1 mg/kg nalbuphine and saline groups. However, 0.2mg/kg nalbuphine caused undesired over-sedation in two (7.7%) children. No other adverse events were reported.
UNASSIGNED: Young children undergoing cochlear implantation surgery were at a high risk of EA and postoperative pain, while 0.2 mg/kg nalbuphine might be an ideal candidate for EA and pain prevention when used under close monitoring.
UNASSIGNED: ChiCTR2000040407.
UNASSIGNED: A prospective double-blinded randomized controlled clinical trial was conducted between November 2020 and October 2022. Eligible children, aged 6 months to 3 years old, were randomly assigned to either 0.1 mg/kg, 0.15 mg/kg, 0.2 mg/kg nalbuphine or 0.9% saline groups. EA was defined by the Pediatric Anesthesia Emergence Delirium (PAED) score ≥10. Extubation time, post-anesthesia care unit (PACU) length of stay, severe EA (PAED ≥ 15), peak PAED score, the Faces, Legs, Activity, Cry, and Consolability (FLACC) scale, Ramsay sedation score, and adverse events were also recorded.
UNASSIGNED: A total of 104 children were enrolled, with 26 children in each group. Nalbuphine significantly reduced the EA occurrence from 73.1% in the saline group to 38.5%, 30.8%, and 26.9% in the 0.1 mg/kg, 0.15 mg/kg, and 0.2 mg/kg nalbuphine groups, respectively (P < 0.001), without affecting the extubation time and PACU length of stay. More children (34.6%) in the 0.9% saline group experienced severe EA. Higher dose nalbuphine (0.15 mg/kg, 0.2 mg/kg) showed lower peak PAED score, better analgesia and sedation effect compared with 0.1 mg/kg nalbuphine and saline groups. However, 0.2mg/kg nalbuphine caused undesired over-sedation in two (7.7%) children. No other adverse events were reported.
UNASSIGNED: Young children undergoing cochlear implantation surgery were at a high risk of EA and postoperative pain, while 0.2 mg/kg nalbuphine might be an ideal candidate for EA and pain prevention when used under close monitoring.
UNASSIGNED: ChiCTR2000040407.
摘要：
■为了研究纳布啡对紧急躁动（EA）的影响，影响到80%的耳鼻喉科手术后的儿童，在接受人工耳蜗植入的儿童中。
■一项前瞻性双盲随机对照临床试验于2020年11月至2022年10月进行。符合条件的儿童，6个月至3岁，被随机分配到0.1毫克/千克，0.15mg/kg,0.2mg/kg纳布啡或0.9%生理盐水组。EA定义为小儿麻醉出现谵妄（PAED）评分≥10。拔管时间,麻醉后监护病房（PACU）住院时间，严重EA（PAED≥15），峰值PAED评分,面孔，腿,活动,哭吧,和可协性(FLACC)量表，Ramsay镇静评分,并记录不良事件.
■共有104名儿童入学，每组有26个孩子。纳布啡将EA的发生率从盐水组的73.1%显著降低至38.5%,30.8%,和26.9%在0.1毫克/千克，0.15mg/kg,和0.2mg/kg纳布啡组，分别为(P<0.001)，不影响拔管时间和PACU住院时间。0.9%生理盐水组中更多儿童（34.6%）出现严重EA。高剂量纳布啡（0.15mg/kg，0.2mg/kg）显示较低的PAED峰值评分，与0.1mg/kg纳布啡和生理盐水组相比，镇痛和镇静效果更好。然而,0.2mg/kg纳布啡在两名（7.7％）儿童中引起了不必要的过度镇静。未报告其他不良事件。
接受人工耳蜗植入手术的幼儿有很高的EA和术后疼痛风险，而在密切监测下使用0.2mg/kg纳布啡可能是EA和疼痛预防的理想候选药物。
■ChiCTR2000040407。
■一项前瞻性双盲随机对照临床试验于2020年11月至2022年10月进行。符合条件的儿童，6个月至3岁，被随机分配到0.1毫克/千克，0.15mg/kg,0.2mg/kg纳布啡或0.9%生理盐水组。EA定义为小儿麻醉出现谵妄（PAED）评分≥10。拔管时间,麻醉后监护病房（PACU）住院时间，严重EA（PAED≥15），峰值PAED评分,面孔，腿,活动,哭吧,和可协性(FLACC)量表，Ramsay镇静评分,并记录不良事件.
■共有104名儿童入学，每组有26个孩子。纳布啡将EA的发生率从盐水组的73.1%显著降低至38.5%,30.8%,和26.9%在0.1毫克/千克，0.15mg/kg,和0.2mg/kg纳布啡组，分别为(P<0.001)，不影响拔管时间和PACU住院时间。0.9%生理盐水组中更多儿童（34.6%）出现严重EA。高剂量纳布啡（0.15mg/kg，0.2mg/kg）显示较低的PAED峰值评分，与0.1mg/kg纳布啡和生理盐水组相比，镇痛和镇静效果更好。然而,0.2mg/kg纳布啡在两名（7.7％）儿童中引起了不必要的过度镇静。未报告其他不良事件。
接受人工耳蜗植入手术的幼儿有很高的EA和术后疼痛风险，而在密切监测下使用0.2mg/kg纳布啡可能是EA和疼痛预防的理想候选药物。
■ChiCTR2000040407。
