在儿童口腔保健中比较计算机化Quicksleeper系统提供的骨内麻醉与传统浸润麻醉疼痛的分口和双臂试验：一项随机对照试验方案
Split-mouth and parallel-arm trials to compare pain with intraosseous anaesthesia delivered by the computerised Quicksleeper system and conventional infiltration anaesthesia in paediatric oral healthcare: protocol for a randomised controlled trial.
作者信息
Smaïl-Faugeron Violaine, Muller-Bolla Michèle, Sixou Jean-Louis, Courson Frédéric
机构信息
Institut National de la Santé et de la Recherche Médicale, U1138, Equipe 22, Centre de Recherche des Cordeliers, Paris, France Service d'Odontologie, Assistance Publique-Hôpitaux de Paris, Hôpital Bretonneau, Paris, France Faculté de Chirurgie Dentaire, Unité de Recherches Biomatériaux Innovants et Interface EA4462, Université Paris Descartes-Sorbonne Paris Cité, Montrouge, France.
Faculté de Chirurgie Dentaire, Unité de Recherches Biomatériaux Innovants et Interface EA4462, Université Paris Descartes-Sorbonne Paris Cité, Montrouge, France Service d'Odontologie, Faculté de Chirurgie Dentaire, Université de Nice-Sophia Antipolis, Nice, France.
出版信息
BMJ Open. 2015 Jul 10;5(7):e007724. doi: 10.1136/bmjopen-2015-007724.
INTRODUCTION
Local anaesthesia is commonly used in paediatric oral healthcare. Infiltration anaesthesia is the most frequently used, but recent developments in anaesthesia techniques have introduced an alternative: intraosseous anaesthesia. We propose to perform a split-mouth and parallel-arm multicentre randomised controlled trial (RCT) comparing the pain caused by the insertion of the needle for the injection of conventional infiltration anaesthesia, and intraosseous anaesthesia by the computerised QuickSleeper system, in children and adolescents.
METHODS AND ANALYSIS
Inclusion criteria are patients 7-15 years old with at least 2 first permanent molars belonging to the same dental arch (for the split-mouth RCT) or with a first permanent molar (for the parallel-arm RCT) requiring conservative or endodontic treatment limited to pulpotomy. The setting of this study is the Department of Paediatric Dentistry at 3 University dental hospitals in France. The primary outcome measure will be pain reported by the patient on a visual analogue scale concerning the insertion of the needle and the injection/infiltration. Secondary outcomes are latency, need for additional anaesthesia during the treatment and pain felt during the treatment. We will use a computer-generated permuted-block randomisation sequence for allocation to anaesthesia groups. The random sequences will be stratified by centre (and by dental arch for the parallel-arm RCT). Only participants will be blinded to group assignment. Data will be analysed by the intent-to-treat principle. In all, 160 patients will be included (30 in the split-mouth RCT, 130 in the parallel-arm RCT).
ETHICS AND DISSEMINATION
This protocol has been approved by the French ethics committee for the protection of people (Comité de Protection des Personnes, Ile de France I) and will be conducted in full accordance with accepted ethical principles. Findings will be reported in scientific publications and at research conferences, and in project summary papers for participants.
TRIAL REGISTRATION NUMBER
ClinicalTrials.gov NCT02084433.
引言
局部麻醉在儿童口腔保健中常用。浸润麻醉是最常用的，但麻醉技术的最新发展引入了一种替代方法：骨内麻醉。我们建议进行一项双侧口内平行组多中心随机对照试验（RCT），比较传统浸润麻醉注射针头插入以及计算机化QuickSleeper系统进行骨内麻醉时在儿童和青少年中引起的疼痛。
方法与分析
纳入标准为7至15岁的患者，至少有2颗属于同一牙弓的第一恒磨牙（用于双侧口内RCT）或有一颗第一恒磨牙（用于平行组RCT），需要进行限于牙髓切断术的保守或牙髓治疗。本研究的开展地点为法国3所大学牙科学院的儿童牙科科室。主要结局指标将是患者在视觉模拟量表上报告的关于针头插入以及注射/浸润过程中的疼痛。次要结局指标为潜伏期、治疗期间额外麻醉的需求以及治疗期间感觉到的疼痛。我们将使用计算机生成的置换区组随机化序列来分配至麻醉组。随机序列将按中心分层（平行组RCT按牙弓分层）。仅参与者对分组情况不知情。数据将按意向性分析原则进行分析。总共将纳入160名患者（双侧口内RCT中30名，平行组RCT中130名）。
伦理与传播
本方案已获得法国保护人类伦理委员会（法兰西岛I区保护人类委员会）批准，并将完全按照公认的伦理原则进行。研究结果将在科学出版物、研究会议以及针对参与者的项目总结报告中公布。
试验注册号
ClinicalTrials.gov NCT02084433。
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