口服咪达唑仑清醒镇静术在儿童牙科充填治疗中的应用效果评价

Evaluation of Oral Midazolam as Conscious Sedation for Pediatric patients in Oral Restoration

目的评价口服咪达唑仑在儿童牙科充填治疗过程中的镇静效果。方法本研究为随机、双盲、对照临床实验,选择5～10岁(平均7.3岁)需进行牙科充填治疗的患儿40名,随机分为两组。试验组术前20分钟口服咪达唑仑(0.5mg/kg),空白对照组术前20分钟口服安慰剂 VitminC 液5ml,两组患儿均配合使用儿童专用束缚带和无痛局麻注射泵。治疗过程拍摄录像,双盲评价治疗依从性和治疗过程中的患儿精神状态情况。同时通过询问患儿,评价顺行性遗忘情况。结果两组患儿治疗过程中的行为和生理指标都有显著性差异,尤其是治疗依从性方面,咪达唑仑组与对照组比较有非常显著性差异(P<0.001)。结论口服咪达唑仑用于儿童牙科治疗镇静术是安全和有效的。同时,由于口服药易于被儿童接受的特点,必将促进这一方法在临床的快速推广。

Objective The purpose of this study was to evaluate the effectiveness of midazolam when sedating young children for dental restorative care.Methods This was a randomly,double-blinded,control clinical study of young uncooperative children.Forty children,ages 5 to 10 years with a mean age of 7.3 years,participated in this study.The subjects were assigned randomly to receive either 0.5 mg/kg of oral mi- dazolam 20 minutes prior to the beginning of dental treatment or the placebo liquid 20 minutes before treatment.All subjects also received painless local anaesthesia and were restrained with children's board and bands.The whole procedure was taped and evaluated every 5 minutes by an expe- rienced pediatric dentist or who was unaware of the drug given to the child.Results:Distinct difference in physiology or behavior was found be- tween groups.Regarding the compliance of dental treatment,a significant difference was observed.Midazolam group showed more children exhibit- ing more compliant.(by Frankl scales:P<0.001)Conclusions Oral midazolam alone is safe and effective sedation for the dental treatment of young children.And oral midazolam application should generally be preferred because it is more easily accepted by pediatric patients.