Intranasal Midazolam in Children as a Pre-Operative Sedative
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Sedation Scale Score
研究概览
简要总结
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.
详细描述
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.
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 otolaryngology (ENT) 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 OBD 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
saline placebo
干预措施: saline placebo (Drug)
Nasal Midazolam only
Nasal Midazolam only - Patients received 0.2 mg/kg of intranasal midazolam
干预措施: Midazolam (Drug)
Midazolam and Xylocaine
Midazolam Plus Xylocaine - Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam
干预措施: Midazolam (Drug)
Midazolam and Xylocaine
Midazolam Plus Xylocaine - Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam
干预措施: xylocaine (Drug)
结局指标
主要结局
Sedation Scale Score
时间窗: 15 minutes post-sedation
Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.
Time From Administration to Discharge
时间窗: Minutes from administration to discharge
次要结局
- Parental Observed Behavioral Distress Score(1 minute post-administration)
- RN Observed Behavioral Distress Score(1 minute post-administration)
- Verbal Complaint(At time of administration)
- Verbal Complaints(1 minute post-administration)
研究者
David A Ullman MD
Attending Physician - Anesthesiology
Bassett Healthcare