Comparative Evaluation of Pain Reduction with Vibration using Speech Simulator versus 2 percent Lignocaine Topical Gel Application Prior to Greater Palatine Nerve Block in 7 to 12 year Old Children-A Randomised Controlled Trial

DETAILED METHODOLOGY  Group A: Vibrations will be given for 1 min before injection, and patient will continue to receive vibrations during injection. For vibration application, the head of the speech stimulator will be covered with any one of the finger parts of a disposable glove, speech stimulator switched on, and vibration will be applied with the mouth piece facing onto the oral mucosa, as close as possible to the site of the injection. Once the procedure is over, the glove will be discarded so that the speech stimulator could be reused after chemical sterilization.

Group B :A total of 0.2-ml lignocaine 2% gel  will be applied with a cotton roll on the dry oral mucosa for 1 min. After waiting for further 1 min, local anesthetic will be injected. All these applications will be followed by injection of 2% lignocaine HCl with 1:80,000 adrenaline at the same site using standard 2 ml syringe and 26-gauge, 1/2-inch needle in all the groups. All injections with topical applications/vibration will be administered on palatal mucosa. Tissues will be dried with cotton gauze before application of any agent. Two researchers will be conducting the study, of which the primary researcher will perform all the injections. Second researcher is an impartial observer who will evaluate the pain during injection using SEM (sound, eye, motor) scale. At the end of  palatal injections, each patient will be asked by the second researcher about the pain experience during injection using Faces Pain Scale (FPS). In SEM scale sound, eye and motor pain reactions of patient will be observed. The reactions will be classified on a scale from 1 to 4 categories: comfort, mild discomfort, moderately painful, and painful for each of the S, E, and M code (Table 1). The S, E, and M values of a child will be added to get SEM score for that child. The second researcher standing at a distance of 1.5 m from the dental chair will evaluatethe patient’s sounds, eye signs, and body movements during injection (Abdelmoniem & Mahmoud 2016). FPS Scale The FPS is a self-report measure of pain intensity developed for children across the age range of 4–16 years which scores the sensation of pain on the widely accepted 0 to 10 metric (Garra et al. 2010; Abdelmoniem & Mahmoud 2016). Following the recording of both the scores, the required maxillary tooth will be extracted.