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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: 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.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).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.ClinicalTrials.gov NCT02084433.

SUBMITTER: Smail-Faugeron V

PROVIDER: S-EPMC4499744 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

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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.

Smaïl-Faugeron Violaine V Muller-Bolla Michèle M Sixou Jean-Louis JL Courson Frédéric F

BMJ open 20150710 7

<h4>Introduction</h4>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 ...[more]

PMID: 26163031

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Project description:BackgroundIrreversible pulpitis is a highly painful inflammatory condition of the dental pulp. The recommended care is the removal of the coronal pulp (pulpotomy) for emergency treatment in multi-rooted teeth. However, achieving adequate analgesia in the case of mandibular molars presents many difficulties according to the dental literature. Intraosseous computerised anaesthesia (ICA), in particular, the QuickSleeper™ system, has already been demonstrated to be clinically efficient, but ICA is known to increase the heart rate reversibly in a manner that depends on the speed of injection. Therefore, accelerated heart rate was examined as a potential adverse effect of this injection. This trial aims to compare the cardiovascular effects and the anaesthetic efficacy of ICA versus inferior alveolar nerve block anaesthesia (IANB) in acute irreversible pulpitis of mandibular molars.MethodsThis study is a non-inferiority prospective, randomised, controlled, single-blind, two-group trial conducted at the Nantes University Hospital. The study design included two parallel arms at a ratio of 1:1 that will allocate seventy-two patients into two groups: the first group will receive QuickSleeper™ intraosseous anaesthesia; the second will receive an inferior alveolar nerve block before emergency treatment (pulpotomy). This study will include patients requiring emergency dental care under local anaesthesia with confirmed irreversible pulpitis in mandibular molars. The primary outcome is the time taken for the fluctuations in the cardiovascular parameters to return to baseline values during endodontic treatment in two different anaesthetic techniques. The secondary outcomes include efficacy of the technique, patient's pain perception before and after care, any post-operative effects, and factors associated with the delay of recovery of cardiovascular parameters between the 2 anaesthetic techniques.DiscussionThis trial will evaluate the factors associated with heart rate increase during local anaesthesia administration. The use of blood pressure and cardiovascular measurements can be considered an asset and additional safety in managing local anaesthesia. Detecting early signs of potential adverse events (AEs), particularly patients with certain medical conditions (cardiac rhythm disorders), would suggest caution in administering anaesthesia.Trial registrationClinicalTrials.gov ID: NCT03802305 registered January 14, 2019. (version no. 1.2; 5 November 2021).

Dataset Information

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.

Publications

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.

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