Effectiveness of Pre Injection Use of Cryoanesthesia as Compared to Topical Anesthetic Gel in Reducing Pain Perception During Palatal Injections
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- subjective pain perception during greater palatine nerve block injection
研究概览
简要总结
The goal of this interventional study is to assess the effectiveness of pre-injection use of topical ice application in decreasing pain perception when administering greater palatine nerve block injections as compared to that of topical 20 % benzocaine anesthetic gel using Visual Analogue Scale (VAS) for subjective pain assessment and Sound, Eye, Motor (SEM) scale for objective pain assessment in adult patients.
The main question it aims to answer are:
- Does topical cooling reduce pain as effectively as topical benzocaine during greater palatine nerve block injections?
- Is there any adverse reactions during and after application of topical ice and 20 % benzocaine gel?
- Is there any difference in patient acceptability to the use of either methods during the administration of greater palatine nerve block.
A split mouth design was used where an anesthetic injection was administered in the left and right posterior palatal area. The same operator administered the injections so as to standardize the flow rate and delivery style. The method of intervention i.e topical ice or topical 20% benzocaine anesthetic gel was randomly allocated to the patient by lottery method. The participants received two palatal injections with an interval of two weeks between the appointments. The subjective pain response of the patients during greater palatine nerve block injection with pre-injection use of topical ice and topical anesthetic gel (20% benzocaine) was recorded using VAS scale. The objective pain response of the patients were recorded by a blinded single observer using SEM scale on the same day of the appointment.
Technique of application of topical ice: A new pack of sterile cotton swabstick that was injected with 0.5ml commercially available bottled water and then freezed the day before the appointment. At the time of intervention the injection site was dried with gauge piece and the frozen cotton swab stick was held by its wooden part and the frozen cotton end was placed on the proposed anesthetic site (palatal mucosa just anterior to the greater palatine foramen) for 1 minute. With the frozen cotton swabstick in place, an injection of 0.5 mL of 2 percent Lidocaine with 1:200,000 epinephrine was administered into the injection site via a 27-gauge short needle.
Technique of application of topical anesthetic gel: After the oral mucosa was dried with a gauze piece, application of 0.2 mL Benzocaine 20% gel was done with a sterile swab stick on the proposed anesthetic site (palatal mucosa just anterior to the greater palatine foramen) for a period of two minutes as shown in figure. With the cotton swabstick in place an injection of 0.5 mL of 2 percent Lidocaine with 1:200,000 epinephrine was administered into the injection site via a 27-gauge short needle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessment of objective pain using Sound, Eye and Motor scale will be done by a single outcome assessor who will be blinded about the intervention technique.
入排标准
- 年龄范围
- 16 Years 至 60 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinically healthy patients ASA I and ASA II with intact palatal mucosa on both sides
- •Procedures that needs administration of greater palatine nerve block
排除标准
- •Hypersensitivity to local anesthetic agent
- •Patient who are physically and mentally sub normal
- •Presence of palatal mucosal lesions
- •Patients on long term neuromodulators for chronic pain
- •Patient not consenting to participate in the study
研究组 & 干预措施
Drug Arm :Topical benzocaine
since its a split mouth study one half of the hard palate will receive topical benzocaine i.e Group A
干预措施: Topical Benzocaine (Drug)
Topical ice
Other half of the palate will receive topical ice i.e Group B
干预措施: Topical ice (Other)
结局指标
主要结局
subjective pain perception during greater palatine nerve block injection
时间窗: Immediatley after the injection
measured using Visual analogue Scale (VAS) - The Visual Analogue Scale (VAS) consisting of a 100 mm straight line with the endpoints marked to denote extreme limits on the left as 'no pain at all' and on the right as 'pain as bad as it could be' was used to record the pain score . The patient was asked to mark their pain level on the line between the two endpoints after receiving the palatal injection. The distance between 'no pain at all' and the mark defined the subject's pain which was measured in millimeters.
objective pain perception during greater palatine nerve block injection
时间窗: During the injection procedure
measured using Sound, Eye and Motor (SEM) scale -The SEM scale was used in the assessment of the relationship between pain and the reactions which the sensation of pain generates in the patient's eyes, bodily movements and verbal expressions of discomfort
次要结局
- Adverse effects(upto 30 minutes after the injection)
- Acceptability regarding the use of either topical ice or topical benzocaine(5 minutes after application)
研究者
Siddhartha Rai
Principal investigator
B.P. Koirala Institute of Health Sciences
