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Abstract：
BACKGROUND: The exact median effective dose (ED50) of intranasal dexmedetomidine combined with oral midazolam sedation for magnetic resonance imaging (MRI) examination in children remains unknow and the aim of this study was to determine the ED50 of their combination.
METHODS: This is a prospective dose-finding study. A total of 53 children aged from 2 months to 6 years scheduled for MRI examination from February 2023 to April 2023 were randomly divided into group D (to determine the ED50 of intranasal dexmedetomidine) and group M (to determine the ED50 of oral midazolam). The dosage of dexmedetomidine and midazolam was adjusted according to the modified Dixon\'s up-and-down method, and the ED50 was calculated with a probit regression approach.
RESULTS: The ED50 of intranasal dexmedetomidine when combined with 0.5 mg∙kg- 1 oral midazolam was 0.39 µg∙kg- 1 [95% confidence interval (CI) 0.30 to 0.46 µg∙kg- 1] while the ED50 of oral midazolam was 0.17 mg∙kg- 1 (95% CI 0.01 to 0.29 mg∙kg- 1) when combined with 1 µg∙kg- 1 intranasal dexmedetomidine. The sedation onset time of children with successful sedation in group D was longer than in group M (30.0[25.0, 38.0]vs 19.5[15.0, 35.0] min, P < 0.05). No other adverse effects were observed in the day and 24 h after medication except one dysphoria.
CONCLUSIONS: This drug combination sedation regimen appears suitable for children scheduled for MRI examinations, offering a more precise approach to guide the clinical use of sedative drugs in children.
BACKGROUND: Chinese Clinical Trial Registry, identifier: ChiCTR2300068611(24/02/2023).
METHODS: This is a prospective dose-finding study. A total of 53 children aged from 2 months to 6 years scheduled for MRI examination from February 2023 to April 2023 were randomly divided into group D (to determine the ED50 of intranasal dexmedetomidine) and group M (to determine the ED50 of oral midazolam). The dosage of dexmedetomidine and midazolam was adjusted according to the modified Dixon\'s up-and-down method, and the ED50 was calculated with a probit regression approach.
RESULTS: The ED50 of intranasal dexmedetomidine when combined with 0.5 mg∙kg- 1 oral midazolam was 0.39 µg∙kg- 1 [95% confidence interval (CI) 0.30 to 0.46 µg∙kg- 1] while the ED50 of oral midazolam was 0.17 mg∙kg- 1 (95% CI 0.01 to 0.29 mg∙kg- 1) when combined with 1 µg∙kg- 1 intranasal dexmedetomidine. The sedation onset time of children with successful sedation in group D was longer than in group M (30.0[25.0, 38.0]vs 19.5[15.0, 35.0] min, P < 0.05). No other adverse effects were observed in the day and 24 h after medication except one dysphoria.
CONCLUSIONS: This drug combination sedation regimen appears suitable for children scheduled for MRI examinations, offering a more precise approach to guide the clinical use of sedative drugs in children.
BACKGROUND: Chinese Clinical Trial Registry, identifier: ChiCTR2300068611(24/02/2023).
摘要：
背景：鼻内右美托咪定联合口服咪达唑仑镇静用于儿童磁共振成像（MRI）检查的确切中位有效剂量（ED50）尚不清楚，本研究的目的是确定其组合的ED50。
方法：这是一项前瞻性剂量研究。将2023年2月至2023年4月进行MRI检查的年龄2个月至6岁的儿童53例随机分为D组（测定鼻内右美托咪定的ED50）和M组（测定口服咪达唑仑的ED50）。右美托咪定和咪达唑仑的剂量按改良的Dixon's上下法调整,用probit回归方法计算ED50。
结果：右美托咪定与0.5mg·kg-1口服咪达唑仑合用时，鼻内右美托咪定的ED50为0.39µg·kg-1[95％置信区间（CI）0.30至0.46µg·kg-1]，而口服咪达唑仑的ED50为0.17mg·kg-1（95％CI与右美托咪定内D组镇静成功患儿的镇静起效时间长于M组(30.0[25.0,38.0]vs19.5[15.0,35.0]min,P<0.05)。除一次烦躁不安外，在用药当天和用药后24小时未观察到其他不良反应。
结论：这种药物联合镇静方案似乎适用于计划进行MRI检查的儿童，提供了更精确的方法来指导儿童镇静药物的临床使用。
背景：中国临床试验注册中心，标识符：ChiCTR2300068611(24/02/2023)。
方法：这是一项前瞻性剂量研究。将2023年2月至2023年4月进行MRI检查的年龄2个月至6岁的儿童53例随机分为D组（测定鼻内右美托咪定的ED50）和M组（测定口服咪达唑仑的ED50）。右美托咪定和咪达唑仑的剂量按改良的Dixon's上下法调整,用probit回归方法计算ED50。
结果：右美托咪定与0.5mg·kg-1口服咪达唑仑合用时，鼻内右美托咪定的ED50为0.39µg·kg-1[95％置信区间（CI）0.30至0.46µg·kg-1]，而口服咪达唑仑的ED50为0.17mg·kg-1（95％CI与右美托咪定内D组镇静成功患儿的镇静起效时间长于M组(30.0[25.0,38.0]vs19.5[15.0,35.0]min,P<0.05)。除一次烦躁不安外，在用药当天和用药后24小时未观察到其他不良反应。
结论：这种药物联合镇静方案似乎适用于计划进行MRI检查的儿童，提供了更精确的方法来指导儿童镇静药物的临床使用。
背景：中国临床试验注册中心，标识符：ChiCTR2300068611(24/02/2023)。
