Comparison of Midazolam Premedication , Audiovisual Distraction and combination in Reducing Pre- and Post-Operative Anxiety in Children Aged 3–6 Years Undergoing Full Mouth Dental Rehabilitation Under General Anesthesia.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- stress levels measured using pulse rate, blood pressure and FLACC scores
研究概览
简要总结
This randomized controlled trial aims to evaluate and compare the effectiveness of oral midazolam premedication and audiovisual distraction (AVD) in reducing anxiety levels in children aged 2 to 6 years undergoing full mouth dental rehabilitation under general anesthesia. Children will be randomly assigned to two groups: one receiving oral midazolam premedication and the other receiving audiovisual distraction using animated videos before induction of anesthesia. Anxiety levels will be assessed preoperatively and postoperatively using validated behavioral and physiological measures. The study seeks to determine the more effective method for managing perioperative anxiety in pediatric dental patients to enhance overall patient experience and outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children who are between 2 to 6 years old 2.Healthy children (ASA II) 3.Body weight within the Inter Quartile Range (IQR) for this age group as defined by the Centers for Disease Control and Prevention 4.No history of adverse reaction to anesthetic drugs or other medication 5.Children with no Physical or Cognitive disablities 6.Patient reporting to the dental operatory for the first time to minimize behavioural bias 7.Children requiring pulp therapy procedures.
排除标准
- •1.Allergy to lidocaine anesthetic drugs or midazolam 2.Local anesthetic or other drug administered within the week before the session in which they participated 3.Highly symptomatic teeth 4.Localised Lesion at the site of injection 5.Children with prior dental experience 6.Patients with developmental or linguistic disorders who cannot communicate properly 7.Children with medications which affect behaviour 8.Medically and systematically compromised patients 9.Patients with cognitive impairments or special needs.
结局指标
主要结局
stress levels measured using pulse rate, blood pressure and FLACC scores
时间窗: Baseline and immediately post full mouth rehabilitation under general anesthesia
次要结局
未报告次要终点