Comparison of Nebulized Dexmedetomidine, Ketamine, or Midazolam for Premedication in Children Undergoing Adenotonsillectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- A five-point sedation score on arrival in the operating room
研究概览
简要总结
The aim of this study is to compare between nebulized dexmedetomidine, ketamine, or midazolam for premedication in children undergoing adenotonsillectomy.
详细描述
The aim of this study is to compare between nebulized dexmedetomidine, ketamine, or midazolam for premedication in children undergoing adenotonsillectomy.
Primary outcome:
• A five-point sedation score on arrival in the operating room 30 min after drug administration.
Secondary outcomes:
- Parental separation anxiety scale.
- Medication and mask acceptance scales.
- Hemodynamic variables.
- Recovery time.
- Postoperative face, legs, activity, cry, and consolability (FLACC) scale.
- Emergence Agitation scale.
- Adverse effects.
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
- None
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 3-7 years.
- •Both sexes.
- •American society of anesthesiologists (ASA) physical status (I-II).
- •Children undergoing adenotonsillectomy.
排除标准
- •Patients with known allergy to the study drugs.
- •Significant organ dysfunction.
- •Cardiac dysrhythmia.
- •Congenital heart disease.
- •Use of psychotropic medication, and mental retardation
研究组 & 干预措施
Group M:midazolam group
(Group M): Patients will receive midazolam 0.2 mg kg -1
干预措施: Group M: midazolam group (Drug)
Group K :nebulized ketamine group
Group K: Patients will receive nebulized ketamine 2 mg kg -1
干预措施: Group K:nebulized ketamine group (Drug)
Group D: dexmedetomidine group
Group D: Patients will receive dexmedetomidine 2 mcg kg -1
干预措施: Group D:dexmedetomidine group (Drug)
结局指标
主要结局
A five-point sedation score on arrival in the operating room
时间窗: 30 min after drug administration
Sedation level will be assessed at the same time points mentioned above using a five-point sedation scale score as follows: 1= agitated, 2= alert, 3= calm, 4= drowsy, and 5=asleep . A score ≥ 3 will be considered as acceptable sedation.
次要结局
- Parental separation anxiety scale(At the end of the operation (2hours))
研究者
Mohamed Mostafa Mohamed Abd Elfatah Elrefaie
Resident in Anesthesiology, Surgical ICU and Pain Medicine
Tanta University