SAFETY AND EFFICACY OF ORAL TRIAZOLAM IN CHILDREN

儿童口服三唑仑的安全性和有效性

• 批准号: 2749352
• 负责人: MARTHA SPIEKER
• 金额: $ 3.78万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-08-01 至 1999-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2749352
• 关键词: behavioral /social science research tag; child (0-11); clinical research; dental anxiety; dentistry; drug adverse effect; human subject; oral administration; pediatric pharmacology; triazolam

The safety and efficacy of most oral benzodiazepines for sedation of children is unknown. Yet, there is ample evidence that adverse events occur with unfortunate regularity during sedation in dental care settings with children. This study is a randomized double blind clinical trial where 96 three-to-five year-old children are assigned to either active drug (o.015 or 0.03 mg/kg) or placebo before dental treatment. The objective of the research is to establish the efficacy, safety, and optimal dosing regimen for oral triazolam in pediatric sedation, a paradigm for surgical premedication, in order to provide a rational clinical pharmacological basis for the use this drug which is commonly used yet currently unapproved. The specific aims are: a. To determine the efficacy of oral triazolam administered as a premedication to children in dental practice in comparison to a placebo. b. To assess the safety of oral triazolam in children. c. To study visual and memory side effects of triazolam in children.

大多数口服苯二氮卓类药物用于镇静的安全性和有效性 儿童未知。 然而，有充分的证据表明不利 不幸的是，在牙科镇静期间，事件经常发生 有儿童的护理环境。 本研究是一项随机双盲研究 一项临床试验，96 名 3 到 5 岁的儿童被分配到 牙科治疗前服用活性药物（o.015 或 0.03 mg/kg）或安慰剂 治疗。 研究的目的是确定功效， 儿科口服三唑仑的安全性和最佳剂量方案 镇静，手术前用药的范例，以便提供 使用该药物的合理临床药理学基础 常用但目前尚未批准。 具体目标是： 一个。确定口服三唑仑作为药物的疗效 与牙科诊所中儿童的术前用药相比 安慰剂。 b.评估儿童口服三唑仑的安全性。 c.研究三唑仑对儿童视觉和记忆的副作用。