Effectiveness of Benzocaine Gelpatch in Reducing Injection Pain in Pediatric Dental Patients:A Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Comparing the tolerability of oral topical anesthetic Topicale GelPatch (Benzocaine 18%) and Benzocaine oral gel 20% after injection
研究概览
简要总结
Local anesthetic administration step is mandatory step for controlling pain before dental procedures. The aim of this study was to compare effectiveness of topical Benzocaine 18% gel patch form and Benzocaine 20% topical gel in reducing pain during injection of local anesthesia in children receiving dental treatment.
详细描述
A sample of 50 children ranging in age from 6 to 8 years who need a bilateral dental treatment in the same arch participated in this study. They were healthy children rated 3 or 4 according to Frankl behavioral rating scale. They were selected from the clinic of Pediatric Dentistry Department, Faculty of Dentistry, Alexandria University.
A randomized split mouth design was done in which each child received both tested topical anesthetics on each side of the arch. The topical anesthetic gel patch or the topical gel application was randomly used at the first or second visits. Pain or discomfort was evaluated during injection using sound, eye, motor (SEM) scale, and after injection using faces pain scale- revised (FPS-R).
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 (Participant, Outcomes Assessor)
盲法说明
- Administration of local anesthetic will be video recorded.
- An independent investigator who is blinded to the type of topical applied will evaluate the outcome from the video recordings.
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ranging in age from 6 to 8 years.
- •Healthy children with no contraindications of use of local anesthetics.
- •Cooperative behavior according to Frankl's scale scores 3 or
- •(appendix I)
- •Patients needing dental interventions on both sides in the same arch that will require palatal or inferior alveolar nerve block injections.
排除标准
- •Uncooperative children or with intellectual or physical disabilities or medical conditions.
- •Children with acute pain or emergency visits.
- •Children with previous negative dental experience.
- •Children receiving premedications or analgesics 48 hours before testing.
- •children/parents not willing to participate.
研究组 & 干预措施
Intervention group
Topicale® topical anesthetic gel patch (Benzocaine 18%)
干预措施: Topicale GelPatch (Benzocaine 18%) (Drug)
control group
Opahl® topical anesthetic gel (Benzocaine 20%)
干预措施: Benzocaine oral gel 20% (Drug)
结局指标
主要结局
Comparing the tolerability of oral topical anesthetic Topicale GelPatch (Benzocaine 18%) and Benzocaine oral gel 20% after injection
时间窗: 4 months
Pain or discomfort was evaluated after injection using faces pain scale-revised (FPS-R). 2- Face Pain Scale- Revised: Scoring the chosen face 0, 2, 4, 6, 8, or 10, counting left to right, so "0" = "no pain" and "10" = "very much pain".
Comparing the tolerability of oral topical anesthetic Topicale GelPatch (Benzocaine 18%) and Benzocaine oral gel 20% during injection
时间窗: 4 months
The aim was to reduce pain and discomfort during injection of local anesthesia in pediatric dental patients. Pain or discomfort was evaluated during injection using sound, eye, motor (SEM) scale Sound, Eye, Motor scale: Grade 1: Comfort * Sound: No sound * Eye: No signs * Motor: Relaxed body and hand Grade 2: Mild discomfort * Sound: Non specific sound * Eye: Dilated without tears * Motor: Muscular contractions of hand Grade 3: Moderate discomfort * Sound: Verbal compliant, louder sound * Eye: Tears, sudden eye movement * Motor: Sudden body and hand movements Grade 4: Severe discomfort * Sound: Verbal compliant shouting, crying * Eye: Crying, tears all over face * Motor: Hand movement for defense, Turning the head to opposite side
次要结局
未报告次要终点
研究者
Dina Youssef Attia
Assistant lecturer
Alexandria University