Myers Gary R, Maestrello Christopher L, Mourino Arthur P, Best Al M
Department of Pediatric Dentistry, Virginia Commonwealth University, Medical College of Virginia, Richmond, Va, USA.
Pediatr Dent. 2004 Jan-Feb;26(1):37-43.
This study was designed to examine the efficacy and safety of submucosal (SM) midazolam and oral chloral hydrate (CH) when used for pediatric conscious sedation in a clinical dental environment.
Twenty children ages 32 to 63 months participated in this institutionally approved study. Selection criteria included good health (ASA I), 2 to 5 years of age, uncooperative behavior, and the need for multiple restorative visits. In a double-blind crossover design, patients were randomly assigned to receive either oral CH (50 mg/kg) and SM midazolam (0.2 mg/kg), or oral CH (50 mg/kg) and SM saline placebo on their first sedation visit. On the second sedation visit, the patient received the opposite drug regimen than the first visit. Nitrous oxide (50%) was used during each sedation visit. Behavior response was rated as quiet (Q), crying (C), movement (M), or struggling (S) every 2.5 minutes through 40 minutes of operative procedures. Sedations were monitored using a capnograph, pulse oximeter, an automated blood pressure cuff, and precordial stethoscope. Respiratory rate (RR), heart rate (HR), and blood pressure (BP) were evaluated for each procedure. Data was analyzed using ANOVA and multinomial repeated-measures logistic regression.
Analysis showed a significant difference in behavior during sedation across drug regimen (chi-square = 55.6, df = 3, P < .0001). Patients given SM midazolam in addition to oral CH showed increased Q rating and decreased C, M, and S ratings. RR, BP, and HR for both groups remained within the normal values for 2- to 5-year-olds.
SM midazolam improved the quality of sedation without compromising safety. Quiet behavior was increased and struggling behavior was decreased. In addition, mean HR, RR, and BP analysis did not deviate from the norm for this age group.
本研究旨在探讨在临床牙科环境中，黏膜下注射咪达唑仑和口服水合氯醛用于小儿清醒镇静时的有效性和安全性。
20名年龄在32至63个月的儿童参与了这项经机构批准的研究。入选标准包括健康状况良好（ASA I级）、2至5岁、行为不合作以及需要多次修复性就诊。采用双盲交叉设计，患者在首次镇静就诊时被随机分配接受口服水合氯醛（50 mg/kg）和黏膜下注射咪达唑仑（0.2 mg/kg），或口服水合氯醛（50 mg/kg）和黏膜下注射生理盐水安慰剂。在第二次镇静就诊时，患者接受与首次就诊相反的药物方案。每次镇静就诊时均使用氧化亚氮（50%）。在40分钟的手术过程中，每2.5分钟对行为反应进行一次评分，分为安静（Q）、哭泣（C）、活动（M）或挣扎（S）。使用二氧化碳监测仪、脉搏血氧仪、自动血压袖带和心前区听诊器对镇静情况进行监测。对每个操作过程评估呼吸频率（RR）、心率（HR）和血压（BP）。使用方差分析和多项重复测量逻辑回归对数据进行分析。
分析显示，不同药物方案在镇静期间的行为存在显著差异（卡方 = 55.6，自由度 = 3，P <.0001）。除口服水合氯醛外还接受黏膜下注射咪达唑仑的患者，安静评分增加，哭泣、活动和挣扎评分降低。两组的RR、BP和HR均保持在2至5岁儿童的正常范围内。
黏膜下注射咪达唑仑可提高镇静质量且不影响安全性。安静行为增加，挣扎行为减少。此外，平均HR、RR和BP分析未偏离该年龄组的正常范围。
