Dexmedetomidine Compared to Ketofol for Sedation in Paediatrics Undergoing Dental Procedures: a Comparative Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- the Number of interruptions
研究概览
简要总结
Dental fear and anxiety remain common problems that should be managed by both the dentist and the anesthetist. The currently available evidence for safe and effective sedative drugs for children undergoing the dental procedure is scarce The aim of this study was to compare the safety and efficacy of intravenous ketofol versus dexmedetomidine (Dex) as premedications a sedative in anxious children undergoing dental pulp therapy
详细描述
This double-blind, parallel-group, randomized clinical study will recruiter anxious children who will undergo dental pulp therapy. The study participants will be allocated into two equal groups. Subjects in group I will receive ketofol solution (ketamine/propofol mixture, each mL contains 5 mg of ketamine plus 10 mg of propofol). A loading dose of 0.125 mL/kg will be administered intravenously (IV) over 10 min, followed by maintenance infusion at a rate of 0.05-0.125 mL/kg/h. Subjects in group II will receive the Dex solution (4 µg/mL). A loading dose of 2 µg/kg will be administered IV over 10 min, followed by a maintenance infusion of 0.1-1 µg/kg/h. Non-invasive blood pressure (mean ABP), peripheral oxygen saturation, heart rate, and respiratory rate will be assessed at baseline, at 2 minutes, then at 5 minutes intervals till 60 minutes. Ramsay sedation and Aldrete's recovery rating scores will be assessed before, during, and after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The pedo-dentist, the independent observer/data collector, and participants will be blind to the type of intervention. The study drugs will be prepared by an anesthesiologist who will not participate in the observation of the data. All the lines and syringes will be wrapped to mask colors of the sedative drugs, and the syringes will be label coded.
入排标准
- 年龄范围
- 5 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA-I children,
- •aged 5-10 years-old,
- •requiring dental pulp therapy
排除标准
- •ASA class ≥ II;
- •previous experience with GA or Conscious sedation (CS);
- •dental treatment expected to exceed 45 minutes;
- •history of allergy to local anesthetics, Dex, propofol, ketamine, eggs, or soya;
- •respiratory tract infections
研究组 & 干预措施
group I received ketamine/propofol (ketofol) solution
ketamine/propofol mixture, each mL contains 5 mg of ketamine plus 10 mg of propofol). A loading dose of 0.125 mL/kg will be administered intravenously (IV) over 10 min, followed by maintenance infusion at a rate of 0.05-0.125 mL/kg/h.
干预措施: Ketamine/ propofol (Drug)
group II received the Dex solution (4 µg/mL
A loading dose of 2 µg/kg will be administered IV over 10 min, followed by a maintenance infusion of 0.1-1 µg/kg/h.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
the Number of interruptions
时间窗: through study completion, an average of 3 month
the Number of interruptions that occurred during the procedure
次要结局
- total dose of rescue drug(through study completion, an average of 3 month)
研究者
Rania Maher Hussien, MD
Lecturer of Anaesthesia and intensive care
Ain Shams University