UNASSIGNED: We conducted a randomized, double-blind, single-center trial on children scheduled for craniotomy. The 255 recruited participants aged 1-12 years were randomly assigned to intraoperatively receive a loading intravenous dose of either dexmedetomidine 1 μg·kg-1 or lidocaine 2 mg·kg-1 or normal saline for 15 min followed by dexmedetomidine 0.5 μg·kg-1·h-1 or lidocaine 1 mg·kg-1·h-1 or normal saline until the sutures of endocranium were completed. The primary outcome was the cumulative sufentanil consumption within 24 h post-surgery.
UNASSIGNED: A total of 241 patients were included in the statistical analysis. The primary outcome did not show any significant differences among the three groups (median (IQR) lidocaine group: 3.36 (1.32-5.64) μg vs. dexmedetomidine group: 3.12 (1.36-6.39) μg vs. control group 3.46 (1.77-7.62) μg, p = 0.485). Among the secondary outcomes, there was a statistically significant but small reduction in sufentanil consumption within 2 h, postoperative FLACC/WBFS/NRS pain scores within 4 h after surgery and postoperative Ramsay sedation scores in dexmedetomidine group (p < 0.05). Regarding postoperative complications, the incidence of electrolyte disturbance within 24 and 48 h after surgery was significantly higher in control group compared to the other two groups. There were no significant differences in intraoperative opioid consumption, postoperative frequency of remedy medication, or length of hospitalization among the three groups. No adverse events related to lidocaine or dexmedetomidine were observed.
UNASSIGNED: There were no significant differences in the primary outcome among the three groups. Although dexmedetomidine showed some benefits in reducing postoperative opioid consumption within the first 2 h and pain intensity within the first 4 h post-surgery, these findings should be interpreted with caution. Further research is required to comprehensively assess the outcomes and determine the optimal administration strategy.
UNASSIGNED: [http://www.chictr.org.cn/index.aspx], identifier [ChiCTR1800019411].
■我们进行了随机,双盲,计划开颅手术的儿童的单中心试验。255名年龄在1-12岁的参与者被随机分配到术中接受右美托咪定1μg·kg-1或利多卡因2mg·kg-1的负荷静脉内剂量或生理盐水15分钟,然后接受右美托咪定0.5μg·kg-1·h-1或利多卡因1mg·kg-1·h-1或生理盐水,直到完成内皮下缝合。主要结果是术后24小时内舒芬太尼的累积消耗量。
■共有241例患者纳入统计分析。主要结局在三组之间没有显着差异(中位数(IQR)利多卡因组:3.36(1.32-5.64)μg与右美托咪定组:3.12(1.36-6.39)μgvs.对照组3.46(1.77-7.62)μg,p=0.485)。在次要结果中,在2小时内舒芬太尼的消耗有统计学意义但很小的减少,右美托咪定组术后4h内FLACC/WBFS/NRS疼痛评分及术后Ramsay镇静评分(p<0.05)。关于术后并发症,与其他两组相比,对照组术后24和48h内电解质紊乱的发生率明显更高。术中阿片类药物消耗量无显著差异,术后补救用药的频率,或三组的住院时间。未观察到与利多卡因或右美托咪定相关的不良事件。
■三组之间的主要结局没有显着差异。尽管右美托咪定在减少术后前2小时内的阿片类药物消耗和术后前4小时内的疼痛强度方面显示出一些益处,这些发现应谨慎解释.需要进一步的研究来全面评估结果并确定最佳的管理策略。
■[http://www.chictr.org.cn/index。aspx],标识符[ChiCTR1800019411]。