Pain Perception in Pediatric Infiltration Anesthesia: A Comparative Evaluation of Spilanthes acmella gel Betel Leaf extract gel and Benzocaine Topical Agent in Children Aged 6-10-years.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To determine whether herbal gels like Spilanthes acmella and betel leaf extract offer comparable or superior pain reduction relative to benzocaine.
研究概览
简要总结
Title: Comparative Evaluation of Spilanthes acmella Gel, Betel Leaf Extract Gel, and 5% Benzocaine Gel for Pain Reduction During Pediatric Infiltration Anesthesia: A Randomized Clinical Trial
Brief Summary: This triple-arm, randomized, controlled, single-blinded clinical trial aims to compare the efficacy of three topical anesthetic agents—Spilanthes acmella gel, betel leaf (Piper betle) extract gel, and 5% benzocaine gel—in reducing pain perception during buccal and palatal infiltration injections in children aged 6 to 10 years.
A total of 60 healthy pediatric patients requiring infiltration anesthesia for routine dental procedures will be randomly allocated into three groups (n = 20 per group). After standardized application of the assigned topical gel for 1 minute, a local infiltration using 2% lignocaine with 1:100,000 epinephrine will be administered. Pain will be assessed using the Wong-Baker Faces Pain Rating Scale (WBFPRS) and FLACC behavioral scale immediately post-injection.
Data will be analyzed using ANOVA and post-hoc Tukey tests to determine statistically significant differences in pain perception between the groups. The study seeks to establish whether phyto-based topical anesthetics can serve as effective, safe, and child-friendly alternatives to conventional agents in pediatric dentistry.
Primary Objective: To compare pain perception during infiltration anesthesia following application of Spilanthes acmella gel, betel leaf extract gel, and 5% benzocaine gel.
Study Design: Randomized, controlled, triple-arm, single-blinded clinical trial.
Sample Size: 60 children (20 per group), aged 6–10 years.
Primary Outcome Measures:
- Wong-Baker Faces Pain Rating Scale (child-reported)
- FLACC Scale (clinician-observed)
Randomization Method: Computer-generated random allocation sequence.
Blinding: Single-blinded (participant and observer blinded; operator not blinded).
Statistical Tools: Descriptive statistics, ANOVA, Tukey post-hoc test (significance at p < 0.05; SPSS v25).
Expected Outcome: To determine whether Spilanthes acmella or betel leaf gel is comparable or superior to benzocaine in reducing injection pain in pediatric patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 6–10 years.
- •Frankl positive behavior rating of 3 and 4.(positive/cooperative).
- •Patients indicated for local anesthesia via infiltration for treatment (extraction procedure).
排除标准
- ••Known allergy to any of the topical agents to be used.
- ••Acute infection or inflammation at injection site.
- ••Specially abled children.
结局指标
主要结局
To determine whether herbal gels like Spilanthes acmella and betel leaf extract offer comparable or superior pain reduction relative to benzocaine.
时间窗: Pre operative and immediately post operative
次要结局
- To establish safe, effective, & child-friendly alternatives for topical anesthesia in pediatric dentistry.
- To establish safe, effective, & child-friendly alternatives for topical anesthesia in pediatric dentistry.(NA)
研究者
Dr Vinaya Kumar Kulkarni
SMBT Dental College and Hospital Sangamner