NCT05883150已完成2 期
Intranasal Versus Nebulized Midazolam in Behaviuor Modification of Preschool Children Undergoing Dental Treatment: A Randomized Clinical Trial
Nourhan M.Aly1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2022年11月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Behavior rating
研究概览
简要总结
The aim of the current study is to compare the effect of intranasal versus nebulized route of administration of midazolam as moderate sedative agents in preschoolers undergoing dental treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Frankl scale score
- •ASA I or II physical status.
- •Dental intervention under local anesthesia not requiring more than 30 minutes.
- •No previous dental experience.
- •Parent/guardian's written consent.
排除标准
- •Dental treatment indicated under general anesthesia.
- •Presence of facial or nasal deformities.
- •History of neurological or cognitive alterations.
- •Mouth breathers
研究组 & 干预措施
Nebulized Midazolam
Experimental
干预措施: Nebulized Midazolam (Drug)
Intranasal Midazolam
Active Comparator
干预措施: Intranasal Midazolam (Drug)
结局指标
主要结局
Behavior rating
时间窗: throughout the sedation session
This will be recorded using the Modified Houpt scale for behavior rating; Sleep, head/oral resistance, crying and overall behavior will be scored on a 6-point scale ranging from 1-6 with higher scores indicating better behavior
次要结局
- Level of sedation(during the sedation procedure (after drug administration until reaching satisfactory sedation))
- Onset of sedation(during the sedation procedure (after drug administration until reaching satisfactory sedation))
研究者
Nourhan M.Aly
Assistant Lecturer of Dental Public Health
University of Alexandria
研究点 (1)
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