Comparative Study to Evaluate the Anesthetic Efficacy and Pain Perception of Buffered 4% Articaine Versus Buffered 2% Lidocaine with Local Anesthesia in Children : A Randomized Split Mouth Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain perception using VAS and FLACC scale
研究概览
简要总结
Effective pain management is a crucial aspect of pediatric dentistry, as it directly affects a child’s comfort, cooperation, and overall experience during dental procedures. Achieving adequate anesthesia is essential for minimizing discomfort and anxiety, allowing for smoother treatments. Local anesthetics play a key role in pain control, with lidocaine being the most commonly used due to its well-established safety and efficacy. However, articaine has gained attention in recent years because of its enhanced diffusion ability, which may provide better anesthesia, particularly in areas with dense bone.
One technique that has been introduced to improve the effectiveness of local anesthetics is buffering, which involves adjusting the anesthetic solution’s pH to be closer to physiological levels. This method has been found to decrease injection pain, speed up the onset of anesthesia, and enhance its overall performance by increasing the availability of active anesthetic molecules. Although both articaine and lidocaine can be buffered, limited research has directly compared their effectiveness in pediatric patients.
This study aims to evaluate the clinical efficacy of buffered 4% articaine versus buffered 2% lidocaine in pediatric dental procedures using a randomized crossover split-mouth design. The primary focus will be on anesthetic onset time, pain perception during injection, and the duration of anesthesia. By analyzing these factors, the study seeks to determine whether buffered articaine provides any significant advantages over buffered lidocaine, offering insights that may help improve pain management strategies in pediatric dentistry
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
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children who are between 6 to 12 years old 2.Healthy children (ASA I) 3.Body weight within the Inter Quartile Range (IQR) for this age group as defined by the Centers for Disease Control and Prevention 4.Willingness to participate in two sessions 5.No history of adverse reaction to anesthetic.
- •6.Children with no Physical or Cognitive disablities 7.Patient reporting to the dental operatory for the first time to minimize behavioural bias 8.Children requiring pulp therapy procedures.
排除标准
- •1.Allergy to lidocaine anesthetic drugs 2.Local anesthetic drug administered within the week before the session in which they participated 3.Highly symptomatic teeth 4.Localised Lesion at the site of infection 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
Pain perception using VAS and FLACC scale
时间窗: At baseline
次要结局
- The start of the action, duration of postoperative analgesia, & occurrence of any problems. The duration of(anesthesia was assessed by the feeling of numbness & the first sign of pain.)