Efficacy of Buccal Versus Intranasal Route of Administration of Midazolam Spray in Behavior Management of Pre-School Dental Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Sleep score
研究概览
简要总结
Purpose of this study was to assess the efficacy of aerosolized midazolam, introduced through buccal versus intranasal mucosa in managing uncooperative children undergoing dental treatment.
详细描述
Thirty six children fulfilling the requirements of having a dental condition that needed treatment in two dental settings, not exceeding thirty minutes each. They were randomly assigned to one of two groups, according to the treatment offered at the first visit. At the first visit, either buccal or intranasal aerosolized midazolam was administered. At the second visit the alternate route was implemented in a cross-over design with a one week washout period. Vital signs were recorded at baseline and at 5 minutes interval throughout the treatment session.
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
- Single (Participant)
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Negative and definitely negative behavior according Frankl's scale.
- •ASA Group I (normal healthy patient without systemic disease) and II (patient with mild systemic disease) with no medical contraindication which rules out the use of midazolam.
- •Children with at least two carious lesions requiring dental intervention in two settings of not more than 30 minute each.
排除标准
- •Children with multiple carious lesions who require treatment under general anesthesia.
研究组 & 干预措施
Buccal midazolam
干预措施: Buccal midazolam (Drug)
Intranasal midazolam
干预措施: Intranasal midazolam (Drug)
结局指标
主要结局
Sleep score
时间窗: after 5 minutes
This will be assessed using modified Houpt scale for behavior rating: 1. Awake, alert. 2. Drowsy, disoriented. 3. Intermittently asleep. 4. Sound asleep.
Crying score
时间窗: after 5 minutes
This will be assessed using modified Houpt scale for behavior rating: 1. Hysterical, demands attention. 2. Continuous, making treatment difficult. 3. Intermittent, mild, does not interfere with treatment. 4. No crying present.
Head/oral resistance score
时间窗: after 5 minutes
This will be assessed using modified Houpt scale for behavior rating: 1. Turns head, refuses to open mouth. 2. Mouth closing, must request to open. 3. Chocking, gagging, spitting. 4. No head/oral resistance present.
Overall behavior
时间窗: immediately after completion of the dental treatment procedures
This will be assessed using modified Houpt scale for behavior rating: 1. Aborted, no treatment performed. 2. Very poor, treatment interrupted, partial treatment completed. 3. Fair, difficult, all treatment completed. 4. Good, some limited crying or movement. 5. Excellent, no crying or movement.
Acceptance of drug administration
时间窗: during the sedation procedure
Assessed by a 3 point Likert scale as follows: (1) the child accepted the drug readily. 2 (fair) the child accepted the drug with some resistance. 3 (poor) the child accepted the drug with great resistance. 4 (refused) the child refused but drug administration was possible after persuasion.
次要结局
未报告次要终点
研究者
Nourhan M.Aly
Assistant Lecturer of Dental Public Health
University of Alexandria