PSYCHOSEDATION AND MONITORING OF PEDIATRIC PATIENTS

儿科患者的心理镇静和监测

• 批准号: 3425260
• 负责人: STEPHEN WILSON
• 金额: $ 2.15万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1988
• 资助国家: 美国
• 起止时间: 1988-07-01 至 1990-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3425260
• 关键词: behavior; blood pressure; carbon dioxide; child (0-11); chloral hydrate; dental anxiety; dosage; electroencephalography; electromyography; heart rate; human subject; oxygen consumption; pulmonary respiration; sedative /hypnotic; topical drug application

Concious sedation is one conventional method of managing young, uncooperative children who have dental restorative needs. There are no well-controlled clinical studies which have systemically investigated the relationships between the variables of psychosedative agents, patient behavior, and multiple physiologic parameters during restorative procedures in pediatric dentistry. The propse of this study is to determine the effects of chloral hydrate (CH) on children's clinical behavior, heart rate (HR), blood pressure (BP), respiratory rate (RR), peripheral oxygen saturation (02), expired carbon dioxide (C02), frontalis electromyographic (EMG) and electroencephalographic (EEG) activity during routine restorative treatment. Three dosages of CH and a placebo will be studied. (CH) dosages will be 25, 50 and 75 mg/kg body weight. CH and the placebo will be administered per oris. The subjects of this pilot study will be 24 young (18-36 months of age), uncooperative children who are healthy, but present with caries in a minimum of four of the six quadrants (anterior and posterior). Four appointment periods will be necessary to complete their individualized treatment. The three dosage levels and placebo per group will vary in a Latin square design with each subject receiving three levels of CH and the placebo across four appointments. Fifteen patients will be assigned to each group constituting the four sequences of drug dosages and placebo in the Latin square design. The behavioral and physiologic responses of the child will be rated and recorded during five general phases (pre-opreative, topical anesthesia, injection of local anesthesia, rubber dam application and cavity preparation) respectively. The child will continue to be monitored post-operatively for 30 minutes or until they can be released to parental care. The operator and rater of the behavior will be "blinded" to drug and placebo. All children will have their teeth restored according to the usual and customary standard care at the clinic. ANOVA and Pearson Product Moment Correlation Coefficient will be used to determine: a) any significant dosage effect of CH and placebo on the physiologic parameters at each recording phase and b) any significant correlation among physiologic parameters, respectively. Chi square analysis will be used to evaluate behavioral response categories per dosage level of CH and placebo in each recorded phase.

清醒镇静是一种常规的年轻人管理方法， 有牙齿修复需求的不合作儿童。 那里 没有良好对照的临床研究， 研究了变量之间的关系， 精神镇静剂、患者行为和多种生理 儿科牙科修复手术期间的参数。 本研究的目的是确定氯醛的作用， 水合物（CH）对儿童临床行为、心率（HR） 血压（BP）、呼吸频率（RR）、外周氧 饱和度（O2），呼出的二氧化碳（CO2），额肌 肌电图（EMG）和脑电图（EEG）活动 在常规的恢复治疗中。 三个剂量的CH和a 将研究安慰剂。 (CH)剂量为25、50和75 mg/kg 体重 CH和安慰剂将经口给药。 本试验性研究的受试者将是24名年轻人（18-36个月， 年龄），不合作的儿童谁是健康的，但目前与 在六个象限中的至少四个象限（前部和后部）中的龋齿 后部）。 需要四个任命期才能完成 个性化治疗。 三个剂量水平和 每组的安慰剂将在拉丁方设计中变化， 受试者接受三种水平的CH和四种水平的安慰剂 约会. 每组将分配15名患者 构成药物剂量和安慰剂的四个序列， 拉丁方设计。 行为和生理反应 儿童将在五个一般阶段中被评定和记录 （术前、表面麻醉、局部麻醉注射， 橡胶坝应用和空腔制备）。 的 术后将继续监测儿童30分钟 或者直到他们被释放给父母照顾。 操作者和 行为的评定者将对药物和安慰剂“不知情”。 所有 孩子们的牙齿将按照常规进行修复， 在诊所的常规护理。 ANOVA和Pearson积矩相关系数将为 用于确定：a）CH的任何显著剂量效应， 安慰剂对每个记录阶段生理参数的影响， B）生理参数之间的任何显著相关性， 分别 卡方分析将用于评估 CH和安慰剂各剂量水平的行为反应类别 在每个记录阶段。