METHODS: This prospective, double-blind, randomized controlled trial was conducted at a tertiary care center. One hundred patients, 2-10 years of age, ASA physical status 1 & 2, scheduled for general anaesthesia were enrolled. Patient\'s presedation behaviour was assessed by the modified Yale Preoperative Anxiety Scale Short Form (mYPAS-SF). Patients in Group D received Dexmedetomidine 1 mcg/kg intranasally, and patients in Group K received Ketamine 5 mg/kg intranasally. After 45 min, patients were transferred to the operating table where intravenous cannulation was carried out and the response to needle insertion was assessed by FLACC scale. Vital signs, including the pulse-oximetry, heart rate and respiratory rate were monitored. Side effects such as nausea, vomiting, and agitation were also recorded.
RESULTS: A significantly higher FLACC score was seen in Group D as compared to Group K (p = 0.001). The mean heart rate between two groups was found to be significantly (p = 0.001) lower in Group D compared to Group K. However, the proportion of adverse events was 8% in patients who received ketamine.
CONCLUSIONS: Intranasal ketamine in a dose of 5 mg/kg is clinically more effective as premedication in children aged 2-10 years in comparison with intranasal dexmedetomidine in a dose of 1 mcg/kg.
方法:这种前瞻性,双盲,随机对照试验在三级护理中心进行.一百个病人,2-10岁,纳入计划用于全身麻醉的ASA身体状况1和2。通过改良的耶鲁术前焦虑量表简表(mYPAS-SF)评估患者的抑郁行为。D组患者鼻内接受右美托咪定1mcg/kg,K组患者鼻内接受氯胺酮5mg/kg。45分钟后,患者被转移到手术台上进行静脉内插管,并通过FLACC量表评估患者对针头插入的反应.生命体征,包括脉搏血氧饱和度,监测心率和呼吸频率。副作用如恶心,呕吐,和躁动也被记录。
结果:与K组相比,D组的FLACC评分明显更高(p=0.001)。与K组相比,D组发现两组之间的平均心率显着降低(p=0.001)。在接受氯胺酮治疗的患者中,不良事件的比例为8%.
结论:与1mcg/kg剂量的鼻内右美托咪定相比,5mg/kg剂量的鼻内氯胺酮作为2-10岁儿童的术前用药在临床上更有效。