Comparison of pain perception during administration of local anesthesia with jet injector and conventional injection technique using Wong- Baker scale in 6-12 years old children – a randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Primary outcome is to assess Pain perception using Wong- Baker scale.
研究概览
简要总结
Needle-relatedpain (NRP)/ Blenophobia occurs most frequently during anesthesia in dentistry.In children, the pain from NRPs can produce an emotional and negative cognitiveresponse towards the procedure. Pain haslong been associated with dentistry and has anunusual relation and is the main reason that leads the patient to seek dental treatment.In addition, dental fear and anxiety are the main causes that may leadpatients to bypass dental appointments. Fear-related behaviors have long beenrecognized as the most serious aspect of patient management and can be animpediment to dental care. For invasiveprocedures, pain control is achieved typically by means of injection of localanesthesia. Although this method is highly effective, it is also the dentalprocedure that is most often associated with anxiety and negative responses.For some patients, the injection itself is painful, and thus the procedure thatis designed to reduce pain may itself result in fear and procrastination.In addition,patients often experience more fear at the sight of a needle during theadministration of local anesthetic than from the treatment itself. Therefore,dentists have attempted to minimize the intensity of NRP associated with anydental problem. The objective fear of thechild during administration of localanesthesia ranges from sight of the needle to the pain that might be associatedwith needle injection, which increases the anxiety of the patient resulting infear of receiving local anesthesia in the future. Thus,there is a need for attempting use of several methods to minimize pain duringadministering local anesthesia. Jet-injectorare needle-free systems that work with the principle of applying anestheticsolution with pressure to penetrate the tissues with spring-loaded devices, ina manner reinforced with pressurized air or gas. To the best of our knowledge, limitedliterature is available on the pain perception of the jet injectors onpediatric population. In this study, we aimed to compare the pain perception ofjet injector method and conventional injection method in a pediatric populationof age 6-12 years.
Primary Objectives: Tocompare the effect of the jet injection and conventional injection method onpain perception in children 6-12 years of age using Wong- Baker scale.
Methodology: Childrencoming in the department of pedodontics and preventive dentistry will beincluded in study and requiring administration of local anesthesia on both sides of maxilla will be included instudy for various procedures. Basedon inclusion criteria, 50 children of age group 6- 12 years will be selectedfor study. Both the genders will have equal opportunity toparticipate in the study.Each child will be assigned for both the jet injector and conventionalinjection technique. Method to be administered first will be decidedalternately and the side determination will be done by flip the coin technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)(—)
- 性别
- All
入选标准
- •Aged between 6 -12 years requiring bilateral maxillary local anesthesia.
- •Having sufficient mouth opening.
- •Operation only on primary teeth decayed teeth that require anesthesia.
- •No history of previous administration of anesthesia.
排除标准
- •Medically compromised patient.
- •Dental phobia.
结局指标
主要结局
Primary outcome is to assess Pain perception using Wong- Baker scale.
时间窗: Specific time at which the outcome will be assessed/estimated i.e. at baseline single intervention
次要结局
- The secondary outcome is to measure pulse rate.(Specific time at which the outcome will be assessed/estimated i.e. before & after intervention.)
