CTRI/2024/07/071230尚未招募2/3 期
Comparison between oral midazolam and intranasal midazolam for sedative premedication in paediatric patients.
Dr Reem Khatib1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年8月5日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare the effectiveness of preoperative Oral Midazolam with Intranasal Midazolam for sedative premedication in paediatric patients.
研究概览
简要总结
It is a randomized, prospective, clinical, double blind comparative study to assess the effectiveness of preoperative oral midazolam with intranasal midazolam for sedative premedication in paediatric patients for degree of sedation, ease of parental separation, response to venepuncture, acceptance to mask and post operative recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •1-5 years aged patients of either sex ASA I – II Patients posted for routine paediatric surgeries Hemodynamically stable patients with all routine investigations within normal limits.
- •Patients whose parents or guardians give written informed consent and are willing their child to be a part of the study.
排除标准
- •6 years and above ASA grade 3 and above known allergy to study drugs nasal pathology.
结局指标
主要结局
To compare the effectiveness of preoperative Oral Midazolam with Intranasal Midazolam for sedative premedication in paediatric patients.
时间窗: Five point sedation score followed by parental separation score will be assessed at the end of 20 minutes from administeration of the drug.
次要结局
- To compare the effectiveness of preoperative Oral Midazolam with Intranasal Midazolam for sedative premedication in paediatric patients.(Acceptance to mask & response to venepuncture will be assessed after 20 minutes of drug administer in the operating room)
研究者
Reem Khatib
Dr D Y Patil Medical College, Hospital and Research Centre
研究点 (1)
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