Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement
研究概览
简要总结
Midazolam is often given before surgery to sedate a patient before anesthesia is given. Children are often given a small dose either by mouth or squirted into the nose. Children will often spit out the oral midazolam, making it difficult to know how much medicine, if any, they have received. Giving midazolam into the nose is more reliable, but children may complain of pain, stinging, and may become upset due to the discomfort. Nosebleeds may also occur when midazolam is squirted alone into the nose. The purpose of this study is to see if adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam easier and more comfortable without affecting how the midazolam works as a sedative. This is follow up to the pilot study, Project # 994. This will expand the previous study, with additional participants and revised xylocaine concentration
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 18 months-7 years, scheduled for a minor Ear/Nose/Throat surgical procedure requiring mask anesthesia
- •American Society of Anesthesiologists (ASA) Class 1 or 2
- •Parent willing and able to provide written informed consent
- •Parent willing and able to complete the Observed Behavioral Distress (OBD) Visual Assessment Scale (VAS)
排除标准
- •ASA Class 3 or greater
- •History of allergy to midazolam or xylocaine
- •Presence of acute respiratory infection at time of surgery
- •Parent unwilling or unable to provide informed consent
- •Parent unwilling or unable to complete the OBD VAS
研究组 & 干预措施
Saline Placebo
Control patients will receive intranasal saline
干预措施: saline placebo (Drug)
Nasal Midazolam Only
Patients will receive 0.2 mg/kg of intranasal midazolam
干预措施: Midazolam (Drug)
Midazolam Plus Xylocaine
Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam.
干预措施: Midazolam (Drug)
Midazolam Plus Xylocaine
Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam.
干预措施: xylocaine (Drug)
结局指标
主要结局
Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement
时间窗: 25 minutes
Pediatric Response to Mask Placement Scale - scaled scored by the anesthesiologist or certified nurse anesthetist (CRNA) at the time of mask placement * 1. Agitated: Previous criteria and/or refuses mask. (worst score) * 2. Alert: Previous criteria and/or initially refuses mask, but accept after persuasion. * 3. Calm: Previous criteria and accepts mask. * 4. Drowsy: Previous criteria and accepts mask. * 5. Asleep: Previous criteria and accepts mask. (best score)
次要结局
- Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room(20 minutes)
研究者
Jennifer Victory, RN, CCRC
Clinical Research Nurse Supervisor
Bassett Healthcare