Effectiveness of Sublingual Versus Intranasal Administration of Dexmedetomidine for Sedation of Children Undergoing Dental Treatment (A Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Acceptance of drug administration
研究概览
简要总结
The aim of this study is to assess the efficacy of Dexmedetomidine drug either used sublingually or intranasally in managing healthy children during dental treatment
详细描述
Each child should fulfill the requirements of having a dental condition which needs treatment in two dental sessions, where each session should not exceed thirty minutes. At the first visit ,either sublingual or intranasal Dexmedetomidine will be used, while at the second visit the alternate route will be implemented in a cross-over design. At least one week interval between the two visits will be secured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Frankl behavior rating score
- •ASA I physical status.
- •Dental intervention under local anesthesia not requiring more than 30 minutes.
- •No previous dental experience.
- •Parent/guardian written consent.
排除标准
- •Dental treatment indicated requiring general anesthesia.
- •Mouth breathers.
- •Patients with acute upper respiratory illness.
- •Medically compromised patients.
- •Cognitively impaired patients.
研究组 & 干预措施
Intranasal Dexmedetomidine
干预措施: Intranasal Dexmedetomidine (Drug)
Sublingual Dexmedetomidine
干预措施: Sublingual Dexmedetomidine (Drug)
结局指标
主要结局
Acceptance of drug administration
时间窗: during the sedation procedure
Assessed by a 4 point Likert scale as follows: 1 (Good) the child accepted the drug without any refusal. 2 (fair) the child accepted the drug with some verbal resistance. 3 (poor) the child accepted the drug with some physical resistance. 4 (refused) the child refused but drug administration was possible after persuation.
Anxiety level
时间窗: during the sedation procedure
Anxiety level during local anesthesia administration will be evaluated using Venham's clinical anxiety scale. 0: Relaxed child, 1: Uneasy, concerned, 2:Child appears scared, 3:Shows reluctance to enter situation, difficulty in correctly assessing situational threat, 4:Anxiety interferes with ability to assess situation.
Level of Sedation
时间窗: during the sedation procedure
Time taken by both routes to reach the desired level of sedation using Wilton et al sedation scale and it is scored as follows: 1. Agitated: Clinging parent and/or crying. 2.Alert: Awake, but not clinging to parent may whimper but not crying. 3.Calm: Sitting or lying comfortably with eyes spontaneously open. 4.Drowsy: Sitting or lying comfortably with eyes spontaneously closing but responds to minor stimulation. 5. Asleep: Eyes closed, rousable, does not respond to minor stimulation.
次要结局
未报告次要终点
研究者
Nourhan M.Aly
Instructor of Dental Public Health; Statistician
University of Alexandria