Evaluation of the Effects of Different Topical Anesthetic Agents on Pain and Anxiety in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 主要终点
- Dental Anxiety Score (MCDASf)
研究概览
简要总结
Dental anxiety and pain associated with local anesthetic injections are among the most common barriers to successful dental treatment in children. Topical anesthetic agents are widely used to reduce discomfort during needle insertion; however, evidence regarding the comparative effectiveness of different formulations remains limited.
This prospective observational study aims to evaluate the effects of four routinely used topical anesthetic applications (benzocaine spray, benzocaine gel, lidocaine spray, and lidocaine gel) on pain and anxiety during local infiltration anesthesia in pediatric dental patients. The study will include 160 healthy children aged 6-8 years who require maxillary infiltration anesthesia for routine dental treatment. The choice of topical anesthetic will be determined by the treating clinician as part of routine clinical practice, and no additional intervention or treatment modification will be performed for research purposes.
Dental anxiety will be assessed using the Modified Child Dental Anxiety Scale-faces version (MCDASf), behavioral responses during local anesthetic administration will be evaluated using the Sound, Eye, and Motor (SEM) scale, and self-reported pain will be measured using the Wong-Baker FACES Pain Rating Scale. Physiological parameters, including heart rate, blood pressure, peripheral oxygen saturation (SpO₂), and body temperature, will be recorded before, during, and after local anesthetic administration. The findings are expected to provide evidence regarding the effectiveness of commonly used topical anesthetic formulations in reducing pain and anxiety during pediatric dental treatment and may contribute to optimizing behavior management strategies in clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 6 to 8 years.
- •Frankl Behavior Rating Scale score of 3 or
- •No previous history of local anesthetic injection for dental treatment.
- •Requiring maxillary infiltration anesthesia for treatment of a maxillary second primary molar.
- •Requiring non-emergency, painless dental treatment.
- •Medically healthy children with no chronic systemic disease, mental disability, or physical disability.
- •Written informed consent obtained from a parent or legal guardian.
排除标准
- •Frankl Behavior Rating Scale score of 1 or
- •Physical or intellectual disability.
- •History of cardiovascular disease, diabetes mellitus, Graves' disease, epilepsy, hyperthyroidism, active infection, phenylketonuria, cardiovascular shock, otorrhea, or otitis.
- •Known hypersensitivity or allergy to benzocaine, lidocaine, or any component of the topical anesthetic formulations.
- •Emergency dental treatment or presence of dental pain requiring urgent intervention.
- •Chronic liver or kidney disease.
- •History of methemoglobinemia.
结局指标
主要结局
Dental Anxiety Score (MCDASf)
时间窗: Baseline (T0) and immediately after local anesthetic administration (T2)
Dental anxiety will be assessed using the Modified Child Dental Anxiety Scale-faces version (MCDASf). Scores range from 8 to 40, with higher scores indicating greater dental anxiety.
Pain During Local Anesthetic Administration
时间窗: Immediately after local anesthetic administration (T2)
Pain perception will be assessed using the Wong-Baker FACES Pain Rating Scale. Scores range from 0 (no pain) to 10 (worst pain imaginable).
Behavioral Response During Local Anesthetic Administration
时间窗: During local anesthetic administration (T1)
Behavioral responses will be evaluated using the Sound, Eye, and Motor (SEM) scale during local anesthetic administration. Higher scores indicate greater pain- and anxiety-related behavioral responses.
次要结局
- Heart Rate(Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2))
- Blood Pressure(Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2))
- Peripheral Oxygen Saturation (SpO₂)(Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2))
- Body Temperature(Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2))
研究者
DİLARA NİL GÜNAÇAR
Associate Professor
Recep Tayyip Erdogan University Training and Research Hospital