Evaluating the Efficacy of Topical Anesthesia in Alleviating Pain During Infiltrate Injection in Abbasi Shaheed Hospital/KMDC
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pain Intensity During Infiltration Injection Assessed by Visual Analogue Scale
研究概览
简要总结
This randomized clinical trial aims to assess whether the application of 5% topical lidocaine before infiltration anesthesia reduces pain in patients undergoing tooth extraction. A total of 120 participants will be randomly assigned to receive either infiltration anesthesia alone or infiltration anesthesia preceded by topical lidocaine. Pain will be evaluated using the Visual Analogue Scale (VAS) at predetermined intervals following the procedure. The study seeks to determine the effectiveness of topical anesthesia as a simple adjunctive measure for improving patient comfort and reducing injection-related pain during routine dental extractions. Findings from this research may help optimize pain management strategies and enhance the overall patient experience in dental practice.
详细描述
This randomized clinical trial is designed to evaluate the effectiveness of 5% topical lidocaine in reducing pain associated with infiltration anesthesia in patients undergoing tooth extraction. Pain during local anesthetic administration remains a common cause of anxiety and fear among dental patients and may negatively affect treatment acceptance, patient cooperation, and overall clinical experience.
The study will be conducted at the Department of Oral and Maxillofacial Surgery, Abbasi Shaheed Hospital, and the Department of Oral Surgery, KMDC. A total of 120 eligible adult patients requiring tooth extraction will be recruited after obtaining informed consent. Participants will be randomly allocated into two groups using sealed opaque envelopes. Group A will receive conventional infiltration anesthesia with 2% lidocaine alone, while Group B will receive 5% topical lidocaine prior to administration of 2% lidocaine infiltration anesthesia.
The primary outcome measure will be pain intensity, assessed using the Visual Analogue Scale (VAS). Pain scores will be recorded at 5, 15, and 30 minutes following the procedure. Relevant demographic and clinical variables, including age, gender, smoking status, diabetes mellitus, and hypertension, will also be collected to evaluate potential confounding factors.
The intervention poses minimal risk to participants, as both topical and infiltrative lidocaine are routinely used and well-established agents in dental practice. Patients with known allergies to lidocaine, pregnant or lactating women, and individuals unwilling to participate will be excluded to ensure participant safety. All participants will receive the standard of care required for tooth extraction irrespective of study allocation.
The anticipated benefit of this study is the generation of evidence regarding the effectiveness of topical anesthesia as an adjunctive measure for reducing injection-related pain. The findings may contribute to improved patient comfort, reduced anxiety, enhanced treatment acceptance, and optimization of pain management protocols in routine dental practice.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients aged 18-65 years of age who underwent extraction of tooth.
- •no intolerance or allergies to lidocaine 2% infiltration and lidocaine 5% topical.
- •Patients should not take sedative analgesics or anxiety medications in the 12 hour prior to extraction
排除标准
- •Pregnant or lactating women.
- •Patient not giving consent to undergo the procedure.
- •Patient with occurrence of skin or mucosal allergy or abnormal reaction at the vascular access site.
结局指标
主要结局
Pain Intensity During Infiltration Injection Assessed by Visual Analogue Scale
时间窗: 5 minutes, 15 minutes, and 30 minutes post-procedure
Pain intensity following infiltration injection will be assessed using a 0-10 cm Visual Analogue Scale (VAS) at 5, 15, and 30 minutes after the procedure
Pain Score (Visual Analogue Scale)
时间窗: 5 minutes, 15 minutes, and 30 minutes post-procedure
Pain intensity following infiltration injection will be assessed using a 0-10 cm Visual Analogue Scale (VAS) at 5, 15, and 30 minutes after the procedure.
次要结局
未报告次要终点
研究者
Farwa Ghulam
Evaluating the Efficacy of Topical Anesthesia in Alleviating Pain During Infiltrate Injection in Abbasi Shaheed Hospital/KMDC
Abbasi Shaheed Hospital
