Nebulized Midazolam vs. Oral Midazolam as a Sedative Premedication in Pediatric Anesthesia: A Randomized Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Time required to reach a satisfactory level of sedation
研究概览
简要总结
This study is to be carried out to compare nebulized and oral midazolam in achievement of a satisfactory level of sedation, Ramsey Sedation Score (RSS) of 4, within 30 mins of midazolam administration in pediatrics.
详细描述
This study is to be carried out to compare nebulized midazolam and oral midazolam in achievement of a satisfactory level of sedation, Ramsey Sedation Score (RSS) of 4, within 30 mins of midazolam administration in pediatric surgical patients.
In Pediatric Specialized Hospital, Cairo University 72 pediatric patients scheduled for undergoing general or uro-surgical operations under general anesthesia will be included in this double-blinded study. Patients will be randomly assigned into two equal groups, each group including 36 patients. In one group 36 children will receive nebulized midazolam 0.2 mg/kg in 3 ml normal saline plus 5 ml clear juice (orally) 30 min before undergoing general anesthesia. In the other group 36 children will receive oral midazolam 0.5 mg/kg in 5 ml clear juice plus nebulizer of 3 ml normal saline 30 min before undergoing GA.
level of sedation will be compared between both groups
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients from 2 to 6 years undergoing uro-surgery and general surgical procedures.
- •Duration of surgery 1-2 hours
- •Gender eligible for the study: both.
- •ASA I-II.
排除标准
- •ASA III-IV
- •Patients with elevated levels of serum ALT, Creatinine.
- •Emergency surgeries.
- •Pre-existing neurologic disease.
- •Parent refusal.
- •History of allergy to midazolam.
- •Patients with atopy or a history of asthma.
- •Lengthy procedures of more than 2 hours
研究组 & 干预措施
nebulized midazolam group
36 children will receive nebulized midazolam 0.2 mg/kg in 3 ml normal saline plus 5 ml clear juice 30 min before undergoing general anesthesia
干预措施: Midazolam nebulized (Drug)
oral midazolam group
36 children will receive oral midazolam 0.5 mg/kg in 5 ml clear juice plus nebulizer of 3 ml normal saline 30 min before undergoing anesthesia
干预措施: Midazolam oral solution (Drug)
结局指标
主要结局
Time required to reach a satisfactory level of sedation
时间窗: from time of applying the nebulizer until 30 minutes
time to reach ramsay sedation score 4
次要结局
- Acceptability of method of administration of midazolam by a grading system(from time of giving midazolam oral or nebulized till 30 minutes)
- changes in oxygen saturation(from start of sedation till 1 hour postoperative at 5 minute intervals)
- changes in heart rate(from start of sedation till 1 hour postoperative at 5 minute intervals)
- Recovery time(time from discontinuation of anesthesia until regaining baseline sedation score at 5 minute intervals)
- Ease of separation from parents(from 30 minutes after receiving midazolam till transfer to operating room)
- acceptability of Face mask by grading systen(from time of applying face mask till time of getting asleep at 1 minute intervals)
- Changes in mean arterial blood pressure(from start of sedation till 1 hour postoperative at 5 minute intervals)
研究者
Sherif Mohamed Abd El Moneim Soaida, MD
Assistant professor
Cairo University