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

Abstract

IntroductionLocal 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 analysisInclusion 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 disseminationThis 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 numberClinicalTrials.gov NCT02084433.

Does computerized anaesthesia reduce pain during local anaesthesia in paediatric patients for dental treatment? A systematic review and meta‐analysis

“…Twelve studies had parallel designs and 7 cross‐over designs . And one mixed design parallel and cross‐over . The sample size ranged from 20 to 158 children, with mean age of 8.41 ± 2.42 years.…”

“…The most used anaesthetic solution for local anaesthesia was lidocaine 2% with epinephrine 1:100 000, which was used in 12 studies; four studies used 2% lidocaine with epinephrine 1:80 000; three studies used 2% mepivacaine with epinephrine 1:100 000, one used 4% articaine with epinephrine 1:100 000, and two studies did not report which anaesthetic solution was used …”

“…As for the anaesthesia site, there was some variation between the studies. Twelve studies carried out local anaesthesia in the maxilla ; three in the mandible, and five in the maxilla and mandible …”

“…Most of the studies that used the mandible as the anaesthesia site performed the inferior alveolar nerve block technique (IANB); only one used the infiltrative technique for the conventional anaesthesia. For the computerized anaesthesia, three used periodontal ligament injection (PDL), one infiltrative technique, two IANB technique, and one intraosseous technique .…”

“…These feelings probably have originated from experiences of pain during previous dental treatments, which demonstrate the importance of pain control during paediatric dental treatment . Local anaesthesia is the most common method to do so, but it is also one of the factors that can trigger fear and anxiety, leading to difficulties for behaviour management in paediatric patients . Considering that severe anxiety and fear may enhance pain perception, it is fundamental to explore approaches that have potential to reduce the pain and discomfort associated with local anaesthesia .…”