Optimal Volumes of Administration for Intranasal Midazolam in Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Median Time (Minutes) After Administration of Intranasal Midazolam Until Patient Achieves Minimal Sedation
研究概览
简要总结
The purpose of this study is to determine exactly how much drug volume should be administered into each nare, so that the drug absorption can be maximized and the amount that runs out of the nose, or is swallowed, is minimized, thereby optimizing the effectiveness of any drug given intranasally. The investigators will determine this ideal "volume of administration" by studying intranasal midazolam in children who require sedation to facilitate laceration repairs. The investigators will evaluate both clinical outcomes as well as pharmacokinetic outcomes associated with each volume of administration. We will block randomize children to receive intranasal midazolam in maximum aliquots of one of the three following VOA: 200 microliters (mcL), 500 mcL, or 1000 mcL.
详细描述
The intranasal route is an effective means of administering sedative medications for children. However, sometimes the child has to receive a certain dose that requires a very large volume to be administered into the nose, because of the types of concentrations of drugs that are available. Most drugs are not concentrated enough so that small volumes can be consistently given, so as a result, sometimes a very large amount of medication is administered intranasally. When the amount is too large, most of the medication either runs back out the nose, or down the back of the nose and throat and is swallowed, instead of being absorbed in the nasal cavity, where it can be quickly absorbed and produce optimal effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1 to 7 years of age, inclusive.
- •Require intranasal midazolam for minimal sedation to facilitate laceration repair.
排除标准
- •Weight less than 10 kg.
- •Known allergy to midazolam.
- •Presence of intranasal obstruction (e.g. mucous or blood) that cannot be readily cleared
- •Inability to speak English or Spanish
- •Developmental delay, psychiatric illness, neurologic impairment, or altered mental status; or illnesses associated with chronic pain (e.g. sickle cell disease, inflammatory bowel disease).
- •Foster children or wards.
研究组 & 干预措施
200 mcL VOA
Intranasal midazolam administered in 200 mcL VOA
干预措施: Intranasal midazolam (Drug)
500 mcL VOA
Intranasal midazolam administered in 500 mcL VOA.
干预措施: Intranasal midazolam (Drug)
1000 mcL VOA
Intranasal midazolam administered in 1000 mcL VOA.
干预措施: Intranasal midazolam (Drug)
结局指标
主要结局
Median Time (Minutes) After Administration of Intranasal Midazolam Until Patient Achieves Minimal Sedation
时间窗: 20 minutes
This outcome is designed to examine time to onset of minimal sedation, defined as a University of Michigan Sedation Score (UMSS) of 1.
次要结局
- Observational Scale of Behavioral Distress - Revised(60 minutes)
- Number of Patients With Physicians Who Were Satisfied or Very Satisfied With Ease of Medication Administration(60 minutes)
研究者
Daniel S Tsze, MD, MPH
Assistant Professor of Pediatrics
Columbia University