Comparison of intranasal midazolam and inhalation nitrous oxide sedation in relation to safety and physiological effects in children.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- onset of sedation
研究概览
简要总结
This study uses intranasal midazolam which has a faster onset of action and immediate absorption as compared to oral midazolam.Midazolam was delivered with a mucosal atomisation device and nasal mask was used for nitrous oxide.
The safety of the procedure plays a vital role and thus both the drugs should be evaluated and compared based on the onset of sedation,level of sedation,safety scale,physiological parameters,recovery time and patient preference .This will help to derive proper knowledge and understanding on the physiological effect and safety for the proper use of the aforementioned drugs in future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •Anxious children requiring pulp therapy.
排除标准
- •respiratory disorders, previous medication with erythromycin and/or anticonvulsant.
结局指标
主要结局
onset of sedation
时间窗: Starting at the beginning of the sedation procedure till the end of the sedation procedure,vitals will be monitored- approximately 30 to 45 minutes depending on the severity of the case
level of sedation
时间窗: Starting at the beginning of the sedation procedure till the end of the sedation procedure,vitals will be monitored- approximately 30 to 45 minutes depending on the severity of the case
physiological parameters at different stages of the procedure
时间窗: Starting at the beginning of the sedation procedure till the end of the sedation procedure,vitals will be monitored- approximately 30 to 45 minutes depending on the severity of the case
safety scale
时间窗: Starting at the beginning of the sedation procedure till the end of the sedation procedure,vitals will be monitored- approximately 30 to 45 minutes depending on the severity of the case
recovery time
时间窗: Starting at the beginning of the sedation procedure till the end of the sedation procedure,vitals will be monitored- approximately 30 to 45 minutes depending on the severity of the case
次要结局
- Recovery time(at the end of the sedation procedure i.e., after 30 to 45 from the start of the procedure)