A Randomized Clinical Trial to Assess Pain and Anxiety During Infiltration Anesthesia Using Dental Anesthesia Injector Versus Conventional Syringe in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pain during injection
研究概览
简要总结
This randomized controlled trial is conducted on pediatric dental patients to compare the effectiveness of local anesthesia administered using a dental anesthesia injector device versus the traditional syringe method. The study aims to assess and compare pain and anxiety levels associated with both methods, using both subjective (self-reported) and objective measures. The goal is to identify an alternative technique that minimizes pain and anxiety in pediatric dental patients.
详细描述
This randomized controlled split-mouth clinical trial aims to assess pain and anxiety in pediatric dental patients during and immediately after the administration of local anesthesia using a dental anesthesia injector device compared to a conventional syringe.
The study will include healthy, cooperative children aged 6 to 8 years, each having at least one vital deeply carious maxillary primary molar with signs and symptoms of reversible pulpitis on each side of the maxilla requiring buccal infiltration anesthesia prior to pulpotomy.
Each child will receive both injection techniques on separate occasions, with random assignment of the injection method to either the right or left side (split-mouth design).
To evaluate pain and anxiety, the following tools will be used:
Pain: Visual Analogue Scale (VAS) Anxiety: Corah Dental Anxiety Scale Physiological measures: Heart rate and oxygen saturation levels, recorded using a pulse oximeter Data will be collected during and immediately after the injection. The aim is to determine whether the dental anesthesia injector provides a less painful and less anxiety-inducing experience compared to the traditional syringe method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •normal healthy patients (ASA I)
- •Undergoing the first dental local anesthesia experience
- •Presence of one at least vital deeply carious maxillary primary molar indicated for pulpotomy on each side of maxilla
- •Score 3 or 4 of Frankl scale of child behavior
排除标准
- •Presence of gingivitis, dental abscess, facial trauma/ injury
- •Administration of analgesic 48 h before randomization
- •Presence of allergy from local anesthesia
研究组 & 干预措施
Dental Anesthesia Injector
Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa.
Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using Dental Anesthesia injector .
干预措施: Dental Anesthesia Injector (Device)
Conventional syringe
Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using conventional syringe
干预措施: conventional syringe (Other)
结局指标
主要结局
Pain during injection
时间窗: The pain felt by patient will be assessed by Visual analogue scale, Pulse rate and Oxygen saturation at day 1 of anesthesia injection.
The pain felt by patient will be assessed by Visual analogue scale which is a subjective scale {rating from 0 (no pain) to 10 (worst pain ) } Pulse rate and oxygen saturation will be assessed also which are objective tools where the normal pulse rate is from 60 to 100 beats per minute, more than normal heart rate for the patient during injection and 1 minute after means anxiety The normal Oxygen saturation of the body is from 95% up to 100% the increase in the rating of the Oxygen saturation during the injection and 1 minute after injection means that the patient feels anxiety
Anxiety felt by the patient
时间窗: the scale will be used at day 1 of anesthesia injection
Anxiety felt by the patient during dental visit will be assessed using Corah Dental Anxiety Scale which is a subjective scale consist of brief questionnaire designed to measure anxiety related to dental visits, each question has 5 answers from a to e (a) answers give rating 1 that mean least anxiety felt and (e) answers give rating 5 that mean sever anxiety. If the total rating of the 4 questions \<9 means that the patient has mild anxiety. If the total rating from 15 to 20 means that the patient has sever anxiety.
次要结局
- Need for additional anesthesia(The assessment will be done during dental visit at day 1 of anesthesia injection)