Ansari Ghassem, Fathi Mahnaz, Ghajari Masoud Fallahinejad, Bargrizan Majid, Eghbali Ahmad
Professor, Department of Pediatric Dentistry, Dental School, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Research Institute of Dental Sciences, Dental School, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
J Dent (Tehran). 2018 Sep;15(5):317-324.
This study aimed to evaluate the effect of oral melatonin and oral midazolam as premedication for intravenous (IV) sedation of pediatric dental patients.
This crossover, double-blind randomized clinical trial was conducted on 23 uncooperative 2-6-year-olds with definitely negative behaviors according to the Frankl's scale. Each child served as their own control. The children were randomly divided into two groups: group I received 0.5mg/kg of oral melatonin one hour before IV sedation, while group II received 0.5mg/kg of oral midazolam 30 minutes before IV sedation on their first visit. Every child received the other premedication on their second visit. The degree of sedation was judged according to the Houpt scale. Physiologic parameters including blood pressure (PB), heart rate (HR), and blood oxygen saturation (SpO2) and side effects including dizziness, nausea, vomiting, and sleepiness were assessed. The parents' and the operator's satisfaction rates were scored. Data were analyzed using paired t-test and Wilcoxon signed-rank test.
There were significant differences in sedation scores between the two sessions (P<0.05). However, there were no significant differences in alterations of physiologic parameters between the two sessions (P>0.05). Nausea and vomiting were more common during the first two hours in the midazolam group (P=0.002). Tremors were more common in the melatonin group (P=0.013). Dizziness was more evident when melatonin was used (P<0.001). The clinician and the parents were more satisfied with the results of midazolam intake (P<0.05).
Premedication with oral midazolam in pediatric patients is superior to that with melatonin with a higher parents' and operator's satisfaction.
本研究旨在评估口服褪黑素和口服咪达唑仑作为儿科牙科患者静脉镇静术前用药的效果。
本交叉、双盲随机临床试验针对23名年龄在2至6岁、根据弗兰克量表确定有明显负面行为的不合作儿童进行。每个孩子都作为自己的对照。孩子们被随机分为两组：第一组在静脉镇静前1小时接受0.5mg/kg的口服褪黑素，而第二组在首次就诊时在静脉镇静前30分钟接受0.5mg/kg的口服咪达唑仑。每个孩子在第二次就诊时接受另一种术前用药。根据豪普特量表判断镇静程度。评估生理参数，包括血压（PB）、心率（HR）和血氧饱和度（SpO2），以及副作用，包括头晕、恶心、呕吐和嗜睡。对家长和操作者的满意率进行评分。使用配对t检验和威尔科克森符号秩检验分析数据。
两次治疗之间的镇静评分有显著差异（P<0.05）。然而，两次治疗之间生理参数的变化没有显著差异（P>0.05）。咪达唑仑组在前两小时内恶心和呕吐更为常见（P=0.002）。震颤在褪黑素组中更为常见（P=0.013）。使用褪黑素时头晕更明显（P<0.001）。临床医生和家长对咪达唑仑摄入的结果更满意（P<0.05）。
儿科患者口服咪达唑仑作为术前用药优于褪黑素，家长和操作者的满意度更高。
