Optimization of Procedural Sedation Protocol Used for Dental Care Delivery in People With Mental Disability
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Level of cooperation of patient when receiving regular dental care
研究概览
简要总结
The study aims to compare procedural sedation protocols, specifically applied for the delivery of regular dental care in persons with a mental disability.
The primary objectives are:
- To assess the level of cooperation during regular dental care using different procedural sedation protocols
- To assess patient safety during regular dental care using different sedation protocols
- To assess patient comfort and possible side-effects after regular dental care using different sedation protocols
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum age 18yrs
- •Patient resides at least 6 months in nursing home "het Gielsbos".
- •Patient always gets a sedative protocol to make dental care delivery possible.
- •Informed consent was obtained from parent/guardian
- •No medical contra-indication for any of tested sedative protocols
排除标准
- •Age under 18yrs
- •The patient is no resident of the nursing home "het Gielsbos" or lives there for less than 6 months.
- •No need for medicinal support during dental treatment
- •No informed consent was obtained by parents or the guardian of the patient.
- •Medical contra-indication for 1 of the sedative protocols
研究组 & 干预措施
Midazolam
Midazolam Mylan 5 mg/ml solution for injection 15mg Oral use Single dose 45 minutes before dental treatment
干预措施: Midazolam Mylan (Drug)
Lorazepam / Valium+Akineton+Dehydrobenzperidol+Atropine sulfat
Lorazepam Mylan 2,5 mg tabletten 2.5mg Oral use Single dose 45 minutes before dental treatment
OR
Valium 10 mg/2 ml solution for injection 10mg Intramuscular use Single dose 45 minutes before dental treatment
-
Akineton 5 mg/ml solution for injection 5mg Intramuscular use Single dose 45 minutes before dental treatment
-
Dehydrobenzperidol 5 mg/2 ml solution for injection 0,000125 ml/cm2 Intramuscular use Single dose 45 minutes before dental treatment
-
Atropine sulfate Sterop 0,25mg/1ml solution for injection 0,25mg Intramuscular use Single dose 45 minutes before dental treatment
干预措施: Lorazepam Mylan (Drug)
Lorazepam / Valium+Akineton+Dehydrobenzperidol+Atropine sulfat
Lorazepam Mylan 2,5 mg tabletten 2.5mg Oral use Single dose 45 minutes before dental treatment
OR
Valium 10 mg/2 ml solution for injection 10mg Intramuscular use Single dose 45 minutes before dental treatment
-
Akineton 5 mg/ml solution for injection 5mg Intramuscular use Single dose 45 minutes before dental treatment
-
Dehydrobenzperidol 5 mg/2 ml solution for injection 0,000125 ml/cm2 Intramuscular use Single dose 45 minutes before dental treatment
-
Atropine sulfate Sterop 0,25mg/1ml solution for injection 0,25mg Intramuscular use Single dose 45 minutes before dental treatment
干预措施: Valium + Akineton + Dehydrobenzperidol + Atropine sulfate (Drug)
结局指标
主要结局
Level of cooperation of patient when receiving regular dental care
时间窗: Participants will be followed for the duration of the dental treatment, an expected average of 30 minutes.
次要结局
- Recording of vital parameters during regular dental care delivery(24 hrs)
- Level of patient comfort and possible side-effects after dental treatment session(24 hrs)