Intranasal Dexmedetomidine Versus Intranasal Midazolam as Sole Sedative Agents for MRI In Pediatrics: A Randomized Double-Blind Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The incidence of successful sedation
研究概览
简要总结
An increasing number of studies have reported the use of dexmedetomidine in clinical practice. However, few studies have reported on the intranasal use of dexmedetomidine in radiological procedures The aim of this work is to compare the efficacy and safety of intranasal dexmedetomidine and intranasal midazolam in pediatrics undergoing MRI.
详细描述
This prospective randomized double-blind clinical trial will be carried out on 60 children undergoing elective MRI in Tanta University Hospitals.
Sixty children will be randomly allocated into two equal groups by computer-generated sequence through sealed opaque envelopes:
Group D: 30 children will be sedated with 2 μg/kg intranasal DEX. Group M: 30 children will be sedated with 0.3 mg/kg intranasal midazolam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 2 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged from 2 to 8 years Both sexes ASA physical status I and II Elective MRI.
排除标准
- •Patient's guardian refusal.
- •Body mass index >30 kg/m2
- •Known allergy to dexmedetomidine or midazolam.
- •Suspected difficult airway.
- •Upper respiratory tract infection
- •Anatomical structural deformity of the nasal cavity.
- •Severe liver or renal impairment.
- •Severe bradycardia or atrioventricular block above II degree type
- •Administration of digoxin or beta blockers
研究组 & 干预措施
Dexmedetomidine Group
30 children will be sedated with 2 μg/kg intranasal dexmedetomidine
干预措施: Dexmedetomidine (Drug)
Midazolam Group
30 children will be sedated with 0.3 mg/kg intranasal midazolam.
干预措施: Midazolam (Drug)
结局指标
主要结局
The incidence of successful sedation
时间窗: One hour
Successful sedation is defined as the time taken to achieve an MOAA/S score of 4 and is the time when the patients are calm and sedated and allow intravenous cannulation and MRI examination without crying or agitation.
次要结局
- The onset time of sedation(One hour)
- The occurrence of Adverse effects(One hour)
- The degree of operator satisfaction(One hour)
研究者
Taysser Mahmoud Abdalraheem
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine
Tanta University