Comparison of Intraosseous Anaesthesia Using a Computerized System (QuickSleeper) to Conventional Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Pain reported by the patient according to the visual analogue scale (VAS)
研究概览
简要总结
The purpose is to compare the efficacy of an intraosseous anaesthesia using a computerized system (QuickSleeper) to a conventional infiltration anesthesia. Our hypothesis is that anesthesia via QuickSleeper system can reduce pain during anesthesia and obtain a more rapid local anesthesia compared to the anesthesia via conventional technique by infiltration.
Design: split-mouth design AND parallel-arm design
详细描述
Local anesthesia is commonly used in oral health care and intra-mucosal infiltration anesthesia is most commonly used by practitioners. Anesthesia may cause children a great deal of anxiety because of the fear of the injection. The latter can be painful if the product is delivered too quickly in the mucosa. Recent developments in the techniques and anesthesia systems allow reducing pain during the injection. In particular, computerized systems (electronically assisted local anesthesia) allow a slow injection limiting pressure. Moreover, these systems look like a pen which prevents the negative impression of the image related to the syringe metal. The intraosseous electronically-assisted anesthesia could be an interesting alternative to conventional infiltration anesthesia by making the act less stressful but also less painful for the child.
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)
入排标准
- 年龄范围
- 7 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •split-mouth randomized controlled trial: patients with at least two first permanent molars requiring the same treatment with anesthesia
- •parallel-arm radnomized controlled trial: patients with first permanent molar requiring treatment with anesthesia
- •vital pulp
- •patient did not take any pain medication 48 hours before randomization
- •non-opposition of the child and two holders of parental participation in the study
- •Treatments can be conservative treatment or endodontic treatment limited to pulpotomy.
排除标准
- •Patients with periodontal disease (periodontal pockets or tooth mobility) or radiological defects (necrosis, furcation or periapical radiolucency)
- •Disabled or autistic patients
- •Patients with cancer, heart disease or sickle cell anemia
结局指标
主要结局
Pain reported by the patient according to the visual analogue scale (VAS)
时间窗: up to 10 minutes
Pain reported by the patient according to the visual analogue scale (VAS) will be evaluated at the end of the injection / infiltration. The assessment will concern the insertion of the needle and the injection / infiltration
次要结局
- need for additional anesthesia during the treatment(1 hour)
- pain felt during the treatment(1 hour)
- latency(up to 15 minutes)
研究者
Frederic COURSON
assistant professor, hospital practitionner
Assistance Publique - Hôpitaux de Paris