Oral Sedation With/Without Nitrous Oxide in Pediatric Dental Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Behavior improvement on the modified Houpt behavioral rating scale
研究概览
简要总结
Aims: The objective of the current study was to evaluate the effectiveness of oral midazolam-hydroxyzine with/without nitrous oxide. Design: This was a randomized split mouth, cross over and triple-blinded clinical study. Thirty uncooperative healthy children aged six to nine, whose needed dental treatments.
详细描述
The purpose of this study was to compare the efficacy of combining oral midazolam-hydroxyzine with/without N2O/O2 in sedating uncooperative schoolchildren undergoing dental treatment. Thirty uncooperative healthy children aged six to nine were randomly selected to receive either one tablet of oral midazolam 7.5 mg and one tablet of hydroxyzine 10 mg with 100% O2 (regimen A), or one tablet of oral midazolam 7.5 mg and one tablet of hydroxyzine 10 mg with 50% N2O/O2 (regimen B) in a crossover design. Behavior was assessed using the modified Houpt behavioral rating scale, by evaluating the videotapes of all patients at both the pretreatment phase (injection, rubber dam RD, operating high-speed handpiece with touching the tooth without drilling) and the treatment phase (drilling, restoration).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Triple (Participant, Care Provider, Outcomes Assessor) Each of the children/parents, the dentist and the outcomes assessors were blinded. To ensure the blindness of the dentist, the inhalation sedation machine was placed in a way that he could not see the flow rate panel or the type of the administered gases.
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA Classification I.
- •minimum weight of 18 kg
- •uncooperative children scored 1 or 2 on Frankle Scale.
- •requiring nonemergency, bilateral mandibular dental treatments under local anesthesia.
排除标准
- •known allergy to midazolam and/or hydroxyzine.
- •upper respiratory tract infection with nasal discharge.
研究组 & 干预措施
A: Midazolam-hydroxyzine with 100% O2
Midazolam-hydroxyzine with 100% O2 was administrated to 30 children. Drug: Oral Medication (midazolam 7.5 mg and hydroxyzine 10 mg) and Inhalation Gas 100% O2 Patients were randomly assigned to received one of two regimens (A,B) in across over design, Behavior was assessed using the modified Houpt behavioral rating scale, by evaluating the videotapes of all patients at both the pretreatment and treatment phases.
干预措施: Midazolam-hydroxyzine with 100% O2 (Drug)
Midazolam-hydroxyzine with 50% N2O/ O2
children received Midazolam-hydroxyzine with 50% N2O/O2, one tablet of oral midazolam 7.5 mg and one tablet of hydroxyzine 10 mg with 50% N2O/O2. Drug: Oral Medication and Inhalation Gas Patients were randomly assigned to received one of two regimens (A,B) in across over design, Behavior was assessed using the modified Houpt behavioral rating scale, by evaluating the videotapes of all patients at both the pretreatment and treatment phases.
干预措施: Midazolam-hydroxyzine with 50% N2O/O2 (Drug)
结局指标
主要结局
Behavior improvement on the modified Houpt behavioral rating scale
时间窗: Behavior assess after 30 min of oral medications administered by evaluate the sessions's videotapes using of Sleep,movement,Head/oral resistance,Cry,Verbal assessments(range1- 4,higher values is the better outcome)of modified Houpt behavioral scale
Behavior assessment improvement related to the addition of N2O/O2 to the combination midazolam-hydroxyzine.
次要结局
未报告次要终点
研究者
Nabih Raslan
Principal investigator
Tishreen University