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

摘要:

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。

Abstract:

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.