Evaluating of Oral Propranolol Effect on Managing Anxiety of Dental Extractions in Children: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Anxiety-1 levels
研究概览
简要总结
Evaluating anxiety, heart rate and behavior during dental extractions after oral dose of either Propranolol, Midazolam or a combination of both in uncooperative pediatric patients.
详细描述
Use of 0.5 mg/kg of Propranolol or a combination of Propranolol and Midazolam for the first time to manage uncooperative pediatric dental patients anxiety, comparing with Midazolam by evaluating anxiety, heart rate and behavior during administration of local anesthesia and extraction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High to extreme fear of tooth or molar anesthesia and removal (Frankl: Definitely negative).
- •Scoring more than 19 points on MCDAS(f).
- •Healthy pediatric patients (ASA I) aging 8-10 years.
- •Indication for primary tooth or molar extraction.
- •Fasting if indicated (severe gag reflex).
- •Airway assessment (Mallampati and tonsillar hypertrophy).
排除标准
- •Asthma or any other obstructive pulmonary disease.
- •Cardiac failure.
- •Cardiac arrhythmia.
- •Renal failure.
- •Diabetes.
- •Current use of another ß-adrenoreceptor antagonist.
- •Current use of anxiolytic or antidepressant medication.
- •Currently in psychotherapy for dental anxiety.
- •Systolic blood pressure <100 mmHg.
- •Diastolic blood pressure <60 mmHg.
- •Active Upper respiratory infection.
研究组 & 干预措施
Propranolol
Patients in this group will be given Propranolol 0.5 mg/Kg orally.
干预措施: Propranolol (Drug)
Midazolam
Patients in this group will be given Midazolam 0.5 mg/Kg orally.
干预措施: Midazolam (Drug)
Propranolol and Midazolam
Patients in this group will be given Propranolol and Midazolam with a dose of 0.5 mg/Kg orally for each drug.
干预措施: Propranolol (Drug)
Propranolol and Midazolam
Patients in this group will be given Propranolol and Midazolam with a dose of 0.5 mg/Kg orally for each drug.
干预措施: Midazolam (Drug)
结局指标
主要结局
Change in Anxiety-1 levels
时间窗: (1) five minutes before medication, (2) 30 minutes post-extraction
Anxiety-1 levels will be evaluated using self-reported faces anxiety scale (also called 'modified child dental anxiety scale). Scale name: Modified Child Dental Anxiety Scale (MCDAS): 1. Relaxed/Not worried. (Better outcome) 2. Very slightly worried. 3. Fairly worried. 4. Worried a lot. 5. Very worried. (Worse outcome)
Change in Anxiety-2 levels
时间窗: (1) 45 minutes after medication, while applying local anesthesia, (2) after 10 minutes of applying the anesthesia and during tooth extraction.
Anxiety-2 levels will be measured using Observational Venham Anxiety Scale Major Issues: 1) Will be measured in 2 phases: * 45 minutes after medication, while applying local anesthesia. * While extracting the tooth. "Venham Anxiety Scale": 0. Relaxed. (Better outcome) 1. Uneasy. 2. Tense. 3. Reluctant. 4. Interference. 5. Out of contact. (Worse outcome)
Change in heart rate
时间窗: (1) 5 minutes before medication, (2) 45 minutes after medication, while applying local anesthesia, (3) after 10 minutes of applying the anesthesia and during tooth extraction, (4) 30 minutes following extraction
using Finger Pulse Oximeter
次要结局
- Change in Behavior((1) 45 minutes after medication, while applying local anesthesia, (2) after 10 minutes of applying the anesthesia and during tooth extraction)