Anaesthetic efficacy and influence on cardiovascular parameters change of intraosseous computerized anaesthesia versus inferior alveolar nerve block anaesthesia in acute irreversible pulpitis of mandibular molars: study protocol for a prospective randomised controlled trial

Abstract Background: Irreversible 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 computerized 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. Methods: This study is a non-inferiority prospective, randomized, 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. Discussion: This 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 through the early detection of signs of potential adverse events (AEs) in particular with patients whose medical condition (Cardiac Rhythm Disorders) suggests caution in administering anaesthesia.Trial registration: ClinicalTrials.gov ID: NCT03802305 registered January 14, 2019. (Version n° 1.2; 5 November 2021)