Prevention of Emergence Delirium in Pediatric Ambulatory Surgery: Single Blinded Randomized Control Study Comparing Intra-nasal Dexmedetomidine With Oral Midazolam.
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Time to onset of pediatric delirium
研究概览
简要总结
Preventing emergent delirium in pediatric ambulatory surgery through preoperative use of intra-nasal Dexmedetomidine and oral Midazolam.
详细描述
Pediatric ambulatory patients will randomly be allocated to one of two groups. Group A which will receive Dexmedetomidine intra-nasally at a dose of 1 mcg/kg, approximately 15-25 minutes before entering the operating room or Group B which will receive Midazolam orally at a dose of 0.5 mg/kg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room. Each subject will receive a Drug Acceptance scale, and Parental Separation Anxiety Scale (PSAS) mask Acceptance Scale to identify the differences in markers associated with pediatric delirium. End tidal Sevoflurane value during the surgery and at the time when patient leaves the OR, amount and dose of oral/rectal acetaminophen given in PACU, child's behavior for 48 hours post-operatively, and documented intake of oral analgesics will be collected to identify the reduced need for post-operative analgesia and behaviors associated with extended pediatric delirium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
The surgeon and post-operative nurses will be masked to the group allocation. Masking will only be revealed if medically necessary.
入排标准
- 年龄范围
- 3 Months 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects age 3 months to 9 years
- •Scheduled to undergo a myringotomy
- •American Society of Anesthesiologists (ASA) classification of I - II.
排除标准
- •Subjects with unrepaired cardiac defects, including cyanotic congenital heart disease.
- •Anyone age 10 years or older.
- •Anyone with an ASA classification of III or higher.
- •Non-English language speaker for whom short form consent is not available.
研究组 & 干预措施
Intra-nasal Dexmedetomidine
Subjects will receive Dexmedetomidine intra-nasally in the preoperative area. It will be administered at a dose of 1 mcg/kg, approximately 15-25 minutes before entering the operating room.
干预措施: Intra-nasal Dexmedetomidine (Drug)
Oral Midazolam
Subjects will receive Midazolam orally in the preoperative area. It will be administered at a dose of 0.5 mg/kg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room.
干预措施: Oral Midazolam (Drug)
结局指标
主要结局
Time to onset of pediatric delirium
时间窗: Zero minutes to 48 hours
Time from when the patient is woken from anesthesia to the onset of delirium.
Time to offset of pediatric delirium
时间窗: Zero minutes to 48 hours
Time from onset of delirium to the offset of delirium.
Duration of pediatric delirium
时间窗: Zero minutes to 48 hours
Total time patient experiences delirium
次要结局
- Drug Acceptance(10-25 minutes prior to surgery)
- Parental Separation Anxiety Scale (PSAS)(0-48 hours)
- Mask Acceptance Scale(1-10 minutes prior to surgery)
- End tidal Sevoflurane value(0-12 hours)
- Rescue analgesia in PACU(0-6 hours post surgery)
- Home Behavior Analysis(12-48 hours)
- Oral analgesic use(Two days post-operative)
研究者
R. Ian Richmond
Assistant Professor, Director of Clinical Operations, Dept of Anesthesiology and Perioperative Medicine
University of Massachusetts, Worcester