Conscious Sedation With Midazolam in Dentally Anxious Patients: Effect of the Administration Route (Oral Versus Intravenous Administration)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Patient level of cooperation which is assessed using the French modified version of Venham scale
研究概览
简要总结
Use lay language.
To compare patient level of cooperation during dental care under conscious sedation with midazolam according to the administration route
详细描述
The progress of the study is described below:
Session 1: intravenous administration of midazolam. Establishment of the individual dose.
Randomisation.
Session 2 :
Group A : oral administration of midazolam : the dose administered is twice the individual dose determined in session 1.
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
- 8 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Patient between 8 and 60 years, regardless of gender
- •Patient in the American Society of Anesthesiologists (ASA) category I ou II.
- •Patient in need of multiple dental care, referred to the Unit of Special Care Dentistry for cooperation difficulties
- •Patients directed to conscious sedation under midazolam because they cannot be approached for more than a very brief examination, or following failure to treat under inhalation sedation (50% N2O/O2), or following poor cooperation during treatment under inhalation sedation (poor cooperation is defined as a score of 3 or more on the French modified version of the Venham scale), or following good cooperation during short and simple treatment under inhalation sedation but in need of more complex rehabilitation.
- •Written consent signed by the patient or his legal guardian
- •Patient accompanied by an accountable person
排除标准
- •- Patient below 8 years or over 60 years-old
- •Patient in the American Society of Anesthesiologists (ASA) category III or more
- •Patient having accepted dental treatment without premedication or sedation, and without declaring dental anxiety, during the month prior to the appointment
- •Patient having received an anxiolytic premedication in the 24 hours preceding the dental care session
- •Patient already treated under midazolam sedation less than a week ago
- •Any medical contraindication to the use of midazolam
研究组 & 干预措施
oral midazolam
oral administration of midazolam : the dose administered is twice the individual dose determined in session 1.
干预措施: Conscious sedation for dental care (Other)
oral midazolam
oral administration of midazolam : the dose administered is twice the individual dose determined in session 1.
干预措施: midazolam (Drug)
intravenous midazolam
intravenous administration of midazolam at the individual dose determined in session 1
干预措施: Conscious sedation for dental care (Other)
intravenous midazolam
intravenous administration of midazolam at the individual dose determined in session 1
干预措施: midazolam (Drug)
结局指标
主要结局
Patient level of cooperation which is assessed using the French modified version of Venham scale
时间窗: During the first dental care procedure (at day 1)
This scale offers a good description of behaviour and anxiety in one score (from0 to 5)
次要结局
- The level of patient stress which is assessed using the French modified version of Venham scale(at T8 (end of dental treatment))
- Satisfaction level of the patient which is assessed using the French modified version of Venham scale(48 hours after dental care (T14).)
- Satisfaction level of the accompanying person which is assessed using the French modified version of Venham scale(48 hours after dental care (T14).)
- Satisfaction level of the operator which is assessed using the French modified version of Venham scale(48 hours after dental care (T14).)