Nebulized Midazolam, Dexmedetomidine, and Their Combination in Sedation of Preschoolers Undergoing Dental Treatment: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Post-operative effects of the sedation
研究概览
简要总结
The aim of the study is to evaluate the effect of nebulized Midazolam, Dexmedetomidine, and their combination as procedural, moderate sedative agents in preschoolers undergoing dental treatment.
详细描述
Dental anxiety and fear related behaviors are global problems in Pediatric Dentistry. Preschoolers represent a dental behavior management problem and there is always a debate over the best behavioral management technique for preschoolers undergoing dental treatment. Moderate sedation is considered as an acceptable option.
Children who need treatment under local anesthesia, for thirty minutes will be included in the study. A total of 72 uncooperative pediatric dental patients, of age range 4-6 years, will be selected from the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. The participants will be randomly allocated into 3 groups that will undergo a procedural sedation session via a nebulizer. Children of group I will receive nebulized solution of 0.5 mg/kg Midazolam, Group II will receive nebulized solution of 5µg/kg Dexmedetomidine, and Group III will receive a nebulized solution of 0.3 mg/kg Midazolam and 3µg/kg Dexmedetomidine respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The researcher, statistician and participants will be blinded to the intervention group. Only the supervisor and the anesthesiologist will be aware of the allocation group. After data collection is completed, the randomization code will be broken to reveal the allocation group.
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range 4-6 years
- •Frankl scale score
- •ASA I or II physical status.
- •Dental intervention under local anesthesia not requiring more than 30 minutes.
- •No previous dental experience.
- •Parent/guardian"s written consent.
排除标准
- •Dental treatment indicated under general anesthesia.
- •Presence of facial deformities.
- •History of neurological or cognitive alterations.
- •Mouth breathers.
研究组 & 干预措施
Midazolam group (MDZ)
Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 0.5 mg/kg Midazolam.
干预措施: Midazolam group (MDZ) (Drug)
Dexmedetomidine group (DEX)
Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 5µg/kg Dexmedetomidine.
干预措施: Dexmedetomidine group (DEX) (Drug)
Combination of Midazolam and Dexmedetomidine (MDZ/DEX)
Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively.
干预措施: Combination of Midazolam and Dexmedetomidine (MDZ/DEX) (Drug)
结局指标
主要结局
Post-operative effects of the sedation
时间窗: immediately after completion of the dental treatment procedures.
This will be assessed according to Modified Vernon et al.
Analgo-sedative effect of each drug
时间窗: during the sedation procedure (from its onset till meeting discharge criteria)
The duration of sedation: defined as the onset of satisfactory sedation until the time of meeting discharge criteria according to the American Academy of Pediatric Dentistry.
Facemask acceptance during drug delivery
时间窗: during the sedation procedure
It will be evaluated according to Zanaty \& Metainy as: poor (terrified, crying and combative), fair (moderate fear of mask not calmed with reassurance), good (slight fear of mask, easily reassured) or excellent (unafraid, cooperative and accepts mask readily)
Effect of sedation on children's future behavior
时间窗: after one week in the follow-up session
Each child's behavior will be reassessed in the follow-up sessions and compared to that at baseline (before dental treatment) using Frankl scale (ranges from 0-4)
The 'ease of treatment completion' sing separate five-point scales.
时间窗: immediately after completion of the dental treatment procedures.
This will be measured using separate five-point scales according to Surendar et al: Score 5 indicates an excellent quiet and cooperative child while score 1 indicates Prohibitive active resistance and crying; treatment cannot be rendered.
Analgo-sedative effect of each drug.
时间窗: during the sedation procedure (from its onset till meeting discharge criteria)
Assessment of the most common procedural side effects such as (hypoxia, respiratory depression, agitation, arrhythmia, bradycardia, hypotension or hypertension, shivering, nausea and vomiting) will be recorded.
Amnesic effect of sedative agents.
时间窗: immediately after completion of the dental treatment procedures.
Anterograde amnesia: will be assessed according to a modification of Bulach et al.
Hemodynamic response of sedative agents.
时间窗: during the sedation procedure (from its onset till meeting discharge criteria)
Vital sign: Oxygen saturation will be monitored using an oximeter
次要结局
未报告次要终点
研究者
Nourhan M.Aly
Clinical Instructor
University of Alexandria