Pain Management Following Myringotomy and Tube Placement: Intranasal Dexmedetomidine Versus Fentanyl
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- FLACC Behavioral Pain Assessment Scale Scores
研究概览
简要总结
This is a study to compare intranasal dexmedetomidine to intranasal fentanyl following anesthesia induction in patients undergoing myringotomy and placement of pressure equalization (PE) tubes in providing analgesia and smoothing emergence from general anesthesia.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •functional status as assigned by the American Society of Anesthesiology (ASA) classification of I or II (no or minimal co-morbid disease)
- •patients scheduled for placement of bilateral myringotomy tubes
排除标准
- •history of allergy to either dexmedetomidine or fentanyl
- •concomitant use of medications which may exaggerate the HR response of dexmedetomidine including digoxin or β-adrenergic antagonists.
研究组 & 干预措施
dexmedetomidine w/ midazolam
Midazolam 0.5 mg/kg given orally pre-op and 1 dose of dexmedetomidine 1mcg/kg given intranasally in OR.
干预措施: Dexmedetomidine (Drug)
dexmedetomidine w/ midazolam
Midazolam 0.5 mg/kg given orally pre-op and 1 dose of dexmedetomidine 1mcg/kg given intranasally in OR.
干预措施: Midazolam (Drug)
fentanyl w/ midazolam
Midazolam 0.5 mg/kg given orally pre-op and 1 dose of fentanyl 2mcg/kg given intranasally in OR.
干预措施: Fentanyl (Drug)
fentanyl w/ midazolam
Midazolam 0.5 mg/kg given orally pre-op and 1 dose of fentanyl 2mcg/kg given intranasally in OR.
干预措施: Midazolam (Drug)
dexmedetomidine w/o midazolam
1 dose of dexmedetomidine 1mcg/kg given intranasally in OR without any pre-medication.
干预措施: Dexmedetomidine (Drug)
fentanyl w/o midazolam
1 dose of fentanyl 2mcg/kg given intranasally in the OR without any pre-medication.
干预措施: Fentanyl (Drug)
结局指标
主要结局
FLACC Behavioral Pain Assessment Scale Scores
时间窗: 30 mins. post-op
FLACC Behavioral Pain Assessment Scale: each of the five categories (F) Face, (L) Legs, (A) Activity, (C) Cry, (C) Consolability is scored from 0-2, which results in a total score between 0 and 10. 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort or pain or both
次要结局
- Recovery From General Anesthesia(30 mins. post-op)
研究者
Joseph D. Tobias
Chairman Dept. of Anesthesiology & Pain Medicine
Nationwide Children's Hospital