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Background: Conventional infiltration anaesthesia (CIA) is the most frequently used in paediatric oral health care. However, other techniques are available, such as intraosseous anaesthesia (IOA), that can beneficiate from newly developed technologies., Aim: To compare the pain caused by CIA and IOA delivered by the computerized system (QuickSleeper™) in children., Design: We used an innovative design consisting in simultaneously conducting a multicentre split-mouth and parallel-arm randomized controlled trial (RCT) to allow for increased power. The primary outcome was pain reported by the patient on a visual analogue scale (0-10 cm) concerning the insertion of the needle and injection., Results: A total of 30 children were included in the split-mouth RCT and 128 in the parallel-arm RCT. We combined treatment effect estimates by using an inverse-variance weighting meta-analysis approach. Pain scores were significantly decreased with IOA vs CIA (mean difference -0.69 cm, 95% confidence intervals -1.13 to -0.25 cm). For each patient enrolled in the split-mouth RCT, about five were enrolled in the parallel-arm RCT, which allowed for not losing any eligible patients., Conclusion: Pain during the insertion of the needle and injection was less with IOA vs CIA in children. The design of this study allowed for increasing statistical power and using all generated evidence. (ClinicalTrials.gov NCT02084433)., (© 2019 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

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., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Background: Intraosseous (IO) anaesthesia has been shown to be effective in children. However, the pain associated with anaesthetic injections, and its acceptance by children, have never been studied., Aim: The aim of this study was to assess the pain associated with the IO injection of 4% articaine with 1 : 200 000 epinephrine using the computerized QuickSleeper' system in a population of children and adolescents., Design: IO anaesthesia was performed on patients aged 10.4 +/- 2.6 years of age. The patients assessed their pain on a faces pain scale (FPS) and on a visual analogue scale (VAS). The operators were also asked to assess signs of patient pain/discomfort., Results: No pain or mild discomfort was reported by, respectively, 81.8% (FPS) and 83.9% (VAS) of the patients. Some 58.9% of children with previous experience of dental anaesthesia reported that computerized IO anaesthesia was more comfortable than traditional infiltration methods. Operators noted signs of discomfort during penetration and injection in 18.3% and 25.3% of the patients, respectively., Conclusions: This study showed that the majority of children reported no pain or mild pain when anaesthetic was administered by computerized needle rotation and solution deposition. This technique holds promise for use by trained paediatric dentists.