The Efficacy OF Oral DexmedetomidineVersus Oral Midazolam/Ketamine ON Parental Separation AND Face Mask Acceptance IN Pediatrics Undergoing Adenotonsillectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Face mask acceptance
研究概览
简要总结
The efficacy of oral dexmedetomidine as sedative versus a combination of oral midazolam plus oral ketamine were compared regarding to satisfactory separation from parents, satisfactory mask induction and postoperative rescue analgesia in Pediatrics undergone Adenotosillectomy
详细描述
After obtaining approval from the research Ethics Committee of the Suez Canal University Hospitals and written informed consent from the parents of each participant, 74 American Society of Anesthesiologists (ASA) physical status I and ІІ children aged 3-10 years scheduled for adenotonsillectomy under general anesthesia were enrolled into the study.
Patients were randomly assigned into one of two equal groups on alternative basis using closed envelope method; 37 patients for each group.
Group (D): Patients who received oral dexmedetomidine (4 µg/kg) mixed with apple juice to fill the syringe up to 10 ml.
Group (MK): Patients who received a combination of oral midazolam (0.5 mg/kg) and oral ketamine (1 mg/kg) mixed with apple juice to fill the syringe up to 10 ml.
Methods:
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 (Participant, Care Provider)
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with ASA I (American Society of Anesthesiologists physical status Grade I) = (normal healthy patients) or ASA II (American Society of Anesthesiologists physical status Grade II) = (patients with mild systemic disease and no functional limitations)
- •Children scheduled for adenotonsillectomy
排除标准
- •Children with central nervous system disorders & neurological problems.
- •Children with inborn errors of metabolism.
- •Obese children (BMI >30 kg/m2).
- •Children with known allergy to dexmedetomidine, midazolam or ketamine.
- •Children who vomit.
- •Children with recent or chronic administration of sedative drugs, antipsychotics or tranquilizers.
研究组 & 干预措施
Dexmedetomidine
Patients received Dexmedetomidine (4 µg/kg) mixed with apple juice to fill the syringe up to 10 ml given orally once.
干预措施: Dexmedetomidine (Drug)
Midazolam/Ketamine
Patients received Midazolam (0.5 mg/kg) and Ketamine (1 mg/kg) mixed with apple juice to fill the syringe up to 10 ml given orally once.
干预措施: Midazolam/Ketamine (Combination Product)
结局指标
主要结局
Face mask acceptance
时间窗: The anesthetist asked the child to blow the balloon for induction and assessment was recorded just after anesthesia induction
Five-point scale was used to assess mask acceptance: 1. = Combative, crying. 2. = Moderate fear of the mask, not easily calmed. 3. = Cooperative with reassurance. 4. = Calm, cooperative. 5. = Asleep, steal induction. (Scores 1 and 2): Unacceptable conditions. (Scores 3, 4 and 5): Acceptable conditions.
次要结局
未报告次要终点
研究者
Mohamed A Elsadany, MD
Lecturer in Anesthesiology
Suez Canal University