Fuks A B, Kaufman E, Ram D, Hovav S, Shapira J
Department of Pediatric Dentistry, Hebrew University, Hadassah Faculty of Dental Medicine, Jerusalem, Israel.
Pediatr Dent. 1994 Jul-Aug;16(4):301-5.
The purpose of this study was to assess the effectiveness of two doses of intranasal midazolam on sedation of young children for dental treatment. Thirty uncooperative children, mean age of 32 months, who needed at least two restorative visits, participated in this study. The patients were assigned randomly to receive either 0.2 mg/kg or 0.3 mg/kg of midazolam intranasally, with the alternate regimen administered at the second appointment. All the children received 50% nitrous oxide, and were restrained in a Papoose Board (Olympic Medical Group, Seattle, WA) with a head holder. Degree of alertness, crying, and movement were evaluated at baseline and at 5-min intervals throughout the procedure. Evaluation of overall behavior at each session was performed by one investigator, blind to the dose, using a separate rating scale. The reliability of ratings was assessed by two investigators from videotapes of the procedures. Statistical analysis showed no differences (P > 0.05) in the behavior of the children receiving the two doses. Successful sedation, as assessed by lack of or minimal crying and/or movement that interrupted treatment, was observed in all the treatment visits with both doses (mean score 4.66 +/- 1.09 for 0.3 mg and 4.40 +/- 1.04 for 0.2 mg). No adverse effects were observed, and all the treatments were completed successfully.
本研究的目的是评估两种剂量的鼻内咪达唑仑对幼儿牙科治疗镇静效果的影响。30名年龄在32个月左右、不合作且至少需要两次修复治疗的儿童参与了本研究。患者被随机分配接受0.2mg/kg或0.3mg/kg的鼻内咪达唑仑,在第二次就诊时给予交替方案。所有儿童均接受50%的氧化亚氮,并使用头部固定器固定在Papoose板(华盛顿州西雅图市奥林匹克医疗集团)中。在基线时以及整个过程中每隔5分钟评估一次警觉程度、哭闹和活动情况。每次治疗时由一名对剂量不知情的研究人员使用单独的评分量表对总体行为进行评估。两名研究人员通过治疗过程的录像带评估评分的可靠性。统计分析表明,接受两种剂量的儿童在行为上没有差异(P>0.05)。在所有治疗过程中,两种剂量均观察到成功的镇静效果,即无哭闹或哭闹轻微和/或无影响治疗的活动(0.3mg组平均评分为4.66±1.09,0.2mg组平均评分为4.40±1.04)。未观察到不良反应,所有治疗均成功完成。