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咪达唑仑滴鼻用于新生儿磁共振镇静的效果研究——前瞻性单盲随机对照研究
王芳会, 张洁, 肖谧, 吴芳, 刘俐, 周熙惠
中国当代儿科杂志 ›› 2020, Vol. 22 ›› Issue (5) : 441-445.
PDF(1417 KB)
PDF(1417 KB)
咪达唑仑滴鼻用于新生儿磁共振镇静的效果研究——前瞻性单盲随机对照研究
Sedative effect of intranasal midazolam in neonates undergoing magnetic resonance imaging: a prospective single-blind randomized controlled study
目的 观察并比较咪达唑仑经鼻吸收与苯巴比妥钠肌肉注射对于新生儿头颅磁共振检查时的镇静效果。方法 将2017年9月至2019年3月间行头颅磁共振检查的70例新生儿随机分为观察组和对照组，每组35例。观察组给予咪达唑仑滴鼻（0.3 mg/kg），对照组给予苯巴比妥钠肌肉注射（10 mg/kg）。应用改良Ramsay镇静评分表评估新生儿镇静情况；同时比较两组磁共振完成情况及不良反应发生情况。结果 观察组给药后20 min时镇静评分最高，后逐渐降低，70 min时降至最低；对照组给药后10 min时镇静评分最低，后逐渐增高，40 min、50 min时达最高，再逐渐降低。两组各时间段镇静评分比较，给药后40 min前观察组镇静评分均高于对照组（P < 0.05）；40~70 min两组镇静评分比较差异均无统计学意义（P > 0.05）。观察组磁共振检查成功率（89%）高于对照组（69%，P < 0.05）。两组不良反应比较，差异无统计学意义（P > 0.05）。结论 咪达唑仑滴鼻用于新生儿头颅磁共振检查的镇静效果优于苯巴比妥钠肌肉注射，且快速易行，安全有效。
Objective To compare intranasal midazolam and intramuscular phenobarbital sodium for their sedative effect in neonates undergoing magnetic resonance imaging (MRI). Methods A total of 70 neonates who underwent cranial MRI from September 2017 to March 2019 were randomized into an observation group and a control group, with 35 cases in each group. The observation group received intranasal drops of midazolam (0.3 mg/kg), and the control group received intramuscular injection of phenobarbital sodium (10 mg/kg). The sedation status of the neonates was evaluated using the Ramsay Sedation Scale. Meanwhile, the two groups were compared for the success rate of MRI procedure and incidence of adverse reactions. Results In the observation group, the sedation score was the highest at 20 minutes post administration, then was gradually decreasing, and decreased to the lowest level at 70 minutes post administration. In the control group, the sedation score was the lowest at 10 minutes post administration, then was gradually increasing, and increased to the highest level at 40 minutes and 50 minutes post administration, followed by a gradual decrease. Comparison of the sedation score at each time period suggested that the sedation score was significantly higher in the observation group than in the control group within 40 minutes post administration (P < 0.05), while there were no significant differences between the two groups in the sedation score after 40 minutes post administration (P > 0.05). The success rate of MRI procedure was significantly higher in the observation group than in the control group (89% vs 69%, P < 0.05). There was no significant difference between the two groups in the incidence of adverse reactions (P > 0.05). Conclusions Intranasal midazolam is superior to intramuscular phenobarbital sodium in the sedative effect in neonates undergoing MRI, with the benefits of being fast, convenient, safe, and effective.
[1] 李欢, 杨健. MRI噪声对听力影响的研究进展[J]. 中华放射学杂志, 2016, 50(2):158-160.
[2] Dao K, Giannoni E, Diezi M, et al. Midazolam as a first-line treatment for neonatal seizures:retrospective study[J]. Pediatr Int, 2018, 60(5):498-500.
[3] 周光勇, 许畅, 于志华, 等. 咪达唑仑鼻内给药治疗儿童癫痫持续状态的Meta分析[J]. 安徽医药, 2019, 23(2):386-390.
[4] Sulton C, Kamat P, Mallory M, et al. The use of intranasal dexmedetomidine and midazolam for sedated magnetic resonance imaging in children:a report from the pediatric sedation research consortium[J]. Pediatr Emerg Care, 2020, 36(3):138-142.
[5] Sado-Filho J, Viana KA, Corrêa-Faria P, et al. Randomized clinical trial on the efficacy of intranasal or oral ketamine-midazolam combinations compared to oral midazolam for outpatient pediatric sedation[J]. PLoS One, 2019, 3:e0213074.
[6] Ghai B, Jain K, Saxena AK, et al. Comparison of oral midazolam with intranasal dexmedetomidine premedication for children undergoing CT imaging:a randomized, double-blind, and controlled study[J]. Paediatr Anaesth, 2017, 27(1):37-44.
[7] Lim EY, Tang IP, Peyman M, et al. 3 Tesla magnetic resonance imaging noise in standard head and neck sequence does not cause temporary threshold shift in high frequency[J]. Eur Arch Otorhinolaryngol, 2015, 272(11):3109-3113.
[8] Jin C, Li H, Li X, et al. Temporary hearing threshold shift in healthy volunteers with hearing protection caused by acoustic noise exposure during 3-T multisequence MR neuroimaging[J]. Radiology, 2018, 286(2):602-608.
[9] Coté CJ, Wilson S. Guidelines for monitoring and management of pediatric patients before, during, and after sedation for diagnostic and therapeutic procedures[J]. Pediatr Dent, 2019, 41(4):26E-52E.
[10] Boriosi JP, Eickhoff JC, Klein KB, et al. A retrospective comparison of propofol alone to propofol in combination with dexmedetomidine for pediatric 3T MRI sedation[J]. Paediatr Anaesth, 2017, 27(1):52-59.
[11] Schulte-Uentrop L, Goepfert MS. Anaesthesia or sedation for MRI in children[J]. Curr Opin Anaesthesiol, 2010, 23(4):513-517.
[12] Carter BS, Brunkhorst J. Neonatal pain management[J]. Semin Perinatol, 2017, 41(2):111-116.
[13] Sahoo S, Kaur M, Tripathy HK, et al. Comparative evaluation of midazolam and clonidine as pediatric oral premedication[J]. Anesth Essays Res, 2013, 7(2):221-227.
[14] Gupta A, Dalvi NP, Tendolkar BA. Comparison between intranasal dexmedetomidine and intranasal midazolam as premedication for brain magnetic resonance imaging in pediatric patients:a prospective randomized double blind trial[J]. J Anaesthesiol Clin Pharmacol, 2017, 33(2):236-240.
[15] Baleine J, Milési C, Mesnage R, et al. Intubation in the delivery room:experience with nasal midazolam[J]. Early Hum Dev, 2014, 90(1):39-43.
[16] Yildirim SV, Guc BU, Bozdogan N, et al. Oral versus intranasal midazolam premedication for infants during echocardiographic study[J]. Adv Ther, 2006, 23(5):719-724.
[17] 杨净月, 徐美玉. 新生儿机械通气的镇痛、镇静药物治疗[J]. 江苏医药, 2019, 45(6):614-618.
[18] 石海艳. 咪达唑仑治疗癫痫持续状态的研究进展[J]. 癫痫与神经电生理学杂志, 2016, 25(3):166-167.
[19] Irikura M, Minami E, Ishitsuka Y, et al. Abnormal movements of Japanese infants following treatment with midazolam in a neonatal intensive care unit:incidence and risk factors[J]. ISRN Pharmacol, 2012, 2012:950603.
