Comparative effectiveness of intranasal dexmedetomidine dosing as premedication in paediatric surgery: Randomized controlled trial

Pooja Agrawal, Puneet Bhuwania
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Abstract

: The use of alpha 2 agonists are now becoming the standard of care pre-medication drug in paediatric patients to induce induction and reduce separation anxiety. A prospective, randomized, double-blind, controlled study was designed to assess and compare the effectiveness and safety of two different strengths of intranasal dexmedetomidine in children between the ages of 2 and 8.: Sixty children between ages 2-8 years and of ASA physical status I or II scheduled for elective surgery were randomly assigned to one of two groups. Group A received 1 µg/kg of intranasal dexmedetomidine while Group B received 2 µg/kg as pre-medication. Patients sedation status, behaviour (mask acceptance) and parental separation scores were assessed over 30 min as primary endpoints along with its effect on haemodynamic and respiratory parameters over the same duration as secondary endpoints.: 7.4% of children in group A while 96.5% of children in group B achieved a satisfactory sedation score, 11.1% of children in group A while 100% of children in group B achieved a satisfactory mask acceptance score and 7.4% of children in group A while 100% of children in group B achieved a satisfactory parent child separation score (p<0.001). We did not observe any clinically significant effects of dexmedetomidine on RR, SpO2, HR or MAP and no child required atropine or supplemental oxygen.: We conclude that 2µg/kg dose as compared to 1µg/kg offers multiple advantages of being good sedative, analgesic and anxiolytic in this age group when used as pre-medication.
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儿科手术前鼻腔注射右美托咪定的疗效比较:随机对照试验
:目前,使用α2激动剂已成为儿科患者用药前的标准药物,以诱导和减轻分离焦虑。我们设计了一项前瞻性、随机、双盲对照研究,以评估和比较两种不同强度的右美托咪定鼻内注射剂对 2 至 8 岁儿童的有效性和安全性:60名年龄在2-8岁之间、ASA身体状况为I级或II级、计划接受择期手术的儿童被随机分配到两组中的一组。A 组接受 1 µg/kg 的右美托咪定鼻内注射,B 组接受 2 µg/kg 的右美托咪定鼻内注射作为术前用药。在 30 分钟内对患者的镇静状态、行为(面罩接受度)和父母分离评分进行评估,并将其对血流动力学和呼吸参数的影响作为次要终点:A组有7.4%的儿童获得了满意的镇静评分,而B组有96.5%的儿童获得了满意的镇静评分;A组有11.1%的儿童获得了满意的面罩接受评分,而B组有100%的儿童获得了满意的面罩接受评分;A组有7.4%的儿童获得了满意的亲子分离评分,而B组有100%的儿童获得了满意的亲子分离评分(P<0.001)。我们没有观察到右美托咪定对RR、SpO2、HR或MAP有任何临床显著影响,也没有患儿需要使用阿托品或补充氧气:我们得出的结论是,2µg/kg剂量与1µg/kg剂量相比,对这一年龄组的患儿具有良好的镇静、镇痛和抗焦虑作用。
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