Comparison of Topical Cryoanethesia and Benzocaine in Pain Perception During Mandibular Nerve Block in Pediatric Patients: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 28
研究概览
简要总结
This clinical study tested and compared two ways (cold-base technique or "cryoanesthesia" and conventional benzocaine gel) to reduce pain from dental injections in children.
Researchers worked with 28 children between 6 and 12 years old who needed injections on both sides of the lower jaw for dental treatment. Each child received cryoanesthesia on one side and 20% benzocaine gel on the other side, in different appointments, and the team measured pain, behavior, heart rate, and blood oxygen levels.
详细描述
Objective
To evaluate and compare pain perception during inferior alveolar nerve block puncture in pediatric patients using cryoanesthesia versus conventional topical benzocaine anesthesia.
Methods: A split-mouth randomized controlled clinical trial was conducted with 28 patients aged 6 to 12 years requiring bilateral inferior alveolar nerve blocks for bilateral lower arch dental treatment. Each participant received both anesthetic techniques in a randomized order on separate appointments, with treatment allocated to contralateral mandibular hemiarches. Primary and secondary outcome measures included pain intensity (Visual Analog Scale), heart rate, oxygen saturation, and behavioral response (FLACC scale).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemic health: No significant medical history or uncontrolled systemic disease.
- •Bilateral dental pathology requiring treatment: At least two teeth (one per mandibular hemiarch) requiring bilateral inferior alveolar nerve blocks for restorative or endodontic treatment.
- •Cooperation level: Frankl behavioral rating scale classification III or IV (positive or very positive).
- •Informed consent/Child assent: Signed informed consent from parent or legal guardian; signed assent from participant (age-appropriate).
排除标准
- •Acute dental emergency requiring immediate treatment.
- •Known hypersensitivity or allergy to benzocaine or other local anesthetics.
- •Known hypersensitivity to cold (cryophobia or cold urticaria).
- •Significant dental anxiety or phobia precluding study participation.
- •Developmental delay or behavioral disorders limiting communication or cooperation.
- •Current use of medications affecting pain perception or hemodynamic parameters.
研究者
José Arturo Garrocho Rangel
Clinical Professor
Universidad Autonoma de San Luis Potosí