Local anesthesia with SleeperOne S4 computerized device vs traditional syringe and perceived pain in pediatric patients: a randomized clinical trial

Local anesthesia is performed in dentistry before clinical procedures to avoid pain. Children can show fear at the sight of the needle and pain at its insertion. To make local anesthesia more comfortable, the use of computer-controlled local anesthetic delivery (CCLAD) systems has been developed to control the flow rate of the anesthetic solution injected through the needle. The aim of the present research is to evaluate and compare the discomfort felt by patients using a traditional syringe and the CCLAD system SleeperOne®, by considering pain, size sensation, bitterness, and vomit. 30 patients were included in the study and randomly assigned to traditional anesthesia or CCLAD. After injection, patients were assessed for the abovementioned outcomes. A Visual Analogue Scale (VAS) from 0 to 10 scores was used. As far as pain is concerned, statistically lower mean values were found in the Trial group (p < 0.05). Instead, concerning size, bitterness and vomit perceptions, no statistically significant differences were found between the groups (p > 0.05). Linear regressions were calculated considering technique, quadrant, dental arch, tooth, dentition, sex, and age as independent variables. The technique has shown to have a significant influence on pain (p < 0.05), with lower values for SleeperOne® device. Pain resulted significantly influenced by the type of dentition (p < 0.05), with higher scores for deciduous one. Moreover, perceived pain decreased with the increase of the age of patients (p < 0.05). At last, bitterness perception scores resulted to be higher for primary first molars (p < 0.05). SleeperOne® device seems to be a valid support for the reduction of pain related to anesthetic injection, especially in children. Further studies should evaluate CCLADs’ uses combined with lidocaine preanesthetic as well as with conscious sedation through nitrous oxide in order to determine possible synergistic effects between these procedures.

Local anesthesia; Pediatric patients; Pedodontics; SleeperOne; Computerized local anesthesia device; Visual analogue scale

[1] McLenon J, Rogers MAM. The fear of needles: a systematic review and meta-analysis. Journal of Advanced Nursing. 2019; 75: 30–42.

[2] Dhindsa A, Pandit I, Srivastava N, Gugnani N. Comparative evaluation of the effectiveness of electronic dental anesthesia with 2% lignocaine in various minor pediatric dental procedures: a clinical study. Contemporary Clinical Dentistry. 2011; 2: 27.

[3] Liu F, Yang K, Wang P, Wu T, Li J, Guo Q. Trends, characteristics, and success rates of treatment for severe early childhood caries under general anesthesia: a retrospective study in northwest China. Journal of Clinical Pediatric Dentistry. 2021; 45: 278–283.

[4] Saxena P, Gupta SK, Newaskar V, Chandra A. Advances in dental local anesthesia techniques and devices: an update. National Journal of Maxillofacial Surgery. 2013; 4: 19–24.

[5] Pozos-Guillén A, Loredo-Cruz E, Esparza-Villalpando V, Martínez-Rider R, Noyola-Frías M, Garrocho-Rangel A. Pain and anxiety levels using conventional versus computer-controlled local anesthetic systems in pediatric patients: a meta-analysis. Journal of Clinical Pediatric Dentistry. 2020; 44: 371–399.

[6] Kwak EJ, Pang NS, Cho JH, Jung BY, Kim KD, Park W. Computer-controlled local anesthetic delivery for painless anesthesia: a literature review. Journal of Dental Anesthesia and Pain Medicine. 2016; 16 :81–88.

[7] Nieuwenhuizen J, Hembrecht EJ, Aartman IH, Krikken J, Veerkamp JS. Comparison of two computerised anaesthesia delivery systems: pain and pain-related behaviour in children during a dental injection. European Archives of Paediatric Dentistry. 2013; 14: 9–13.

[8] Hembrecht EJ, Nieuwenhuizen J, Aartman IHA, Krikken J, Veerkamp JSJ. Pain-related behaviour in children: a randomised study during two sequential dental visits. European Archives of Paediatric Dentistry. 2013; 14: 3–8.

[9] Badr N, Aps J. Efficacy of dental local anesthetics: a review. Journal of Dental Anesthesia and Pain Medicine. 2018; 18: 319–332.

[10] American Academy of Pediatric Dentistry. Behavior guidance for the pediatric dental patient. The Reference Manual of Pediatric Dentistry. American Academy of Pediatric Dentistry: Chicago, Ill. 2021.

[11] Sirintawat N, Sawang K, Chaiyasamut T, Wongsirichat N. Pain measure-ment in oral and maxillofacial surgery. Journal of Dental Anesthesia and Pain Medicine. 2017; 17: 253–263.

[12] Palm AM, Kirkegaard U, Poulsen S. The wand versus traditional injection for mandibular nerve block in children and adolescents: perceived pain and time of onset. Pediatric Dentistry. 2004; 26: 481–484.

[13] Monteiro J, Tanday A, Ashley PF, Parekh S, Alamri H. Interventions for increasing acceptance of local anaesthetic in children and adolescents having dental treatment. Cochrane Database of Systematic Reviews. 2020; 2: CD011024.

[14] Guinot F, Virolés M, Lluch C, Costa AL, Veloso A. Spanish and portuguese parental acceptance of behavior management techniques in pediatric dentistry. Journal of Clinical Pediatric Dentistry. 2021; 45: 247–252.

[15] Ciftci V, Yazicioglu İ. A retrospective comparison of dental treatment under general anesthesia provided for uncooperative healthy patients and patients with special health care needs. Journal of Clinical Pediatric Dentistry. 2020; 44: 196–201.

[16] Kharouba J, Somri M, Hadjittofi C, Hasan J, Blumer S. Effectiveness and safety of nitrous oxide as a sedative agent at 60% and 70% compared to 50% concentration in pediatric dentistry setting. Journal of Clinical Pediatric Dentistry. 2020; 44: 60–65.

[17] Langthasa M, Yeluri R, Jain AA, Munshi AK. Comparison of the pain perception in children using comfort control syringe and a conventional injection technique during pediatric dental procedures. Journal of Indian Society of Pedodontics and Preventive Dentistry. 2012; 30: 323–328.

[18] Baghlaf K, Alamoudi N, Elashiry E, Farsi N, El Derwi DA, Abdullah AM. The pain-related behavior and pain perception associated with computerized anesthesia in pulpotomies of mandibular primary molars: a randomized controlled trial. Quintessence International. 2015; 46: 799–806.

[19] Thoppe-Dhamodhara YK, Asokan S, John BJ, PollachiRamakrishnan G, Ramachandran P, Vilvanathan P. Cartridge syringe vs. computer controlled local anesthetic delivery system: pain related behaviour over two sequential visits–a randomized controlled trial. Journal of Clinical and Experimental Dentistry. 2015; 7: e513–518.

[20] Feda M, Al Amoudi N, Sharaf A, Hanno A, Farsi N, Masoud I, et al. A comparative study of children’s pain reactions and perceptions to AMSA injection using CCLAD versus traditional injections. Journal of Clinical Pediatric Dentistry. 2010; 34: 217–222.

[21] Mittal M, Kumar A, Srivastava D, Sharma P, Sharma S. Pain perception: computerized versus traditional local anesthesia in pediatric patients. Journal of Clinical Pediatric Dentistry. 2015; 39: 470–474.

[22] Patil A, Saurabh S, Pragya P, Aijazuddin A, Chandra S, Singh Chawla J. Comparative assessment of perceived pain in children during palatal anesthesia using two injection techniques: an in vivo study. Journal of Pharmacy and Bioallied Sciences. 2022; 14: 503.

[23] O’Neal LY, Nusstein J, Drum M, Fowler S, Reader A, Ni A. Comparison of maxillary lateral incisor infiltration pain using the dentapen and a traditional syringe: a prospective randomized study. Journal of Endodontics. 2022; 48: 840–844.

[24] Flisfisch S, Woelber JP, Walther W. Patient evaluations after local anesthesia with a computer-assisted method and a conventional syringe before and after reflection time: a prospective randomized controlled trial. Heliyon. 2021; 7: e06012.

[25] Riba-Roca A, Figueiredo R, Malamed S, Arnabat-Dominguez J. A randomized split-mouth clinical trial comparing pain experienced during palatal injections with two different computer-controlled local anesthetic delivery systems. Journal of Clinical and Experimental Dentistry. 2020; 12: e1139–e1144.

[26] Smolarek PDC, da Silva LS, Martins PRD, Hartman KDC, Bortoluzzi MC, Chibinski ACR. Evaluation of pain, disruptive behaviour and anxiety in children aging 5–8 years old undergoing different modalities of local anaesthetic injection for dental treatment: a randomised clinical trial. Acta Odontologica Scandinavica. 2020; 78: 445–453.

[27] Saoji H, Nainan MT, Nanjappa N, Khairnar MR, Hishikar M, Jadhav V. Assessment of computer-controlled local anesthetic delivery system for pain control during restorative procedures: a randomized controlled trial. Journal of Dental Research, Dental Clinics, Dental Prospects. 2019; 13: 298–304.

[28] Al-Obaida MI, Haider M, Hashim R, AlGheriri W, Celur SL, Al-Saleh SA, et al. Comparison of perceived pain and patients’ satisfaction with traditional local anesthesia and single tooth anesthesia: a randomized clinical trial. World Journal of Clinical Cases. 2019; 7: 2986–2994.

[29] Alamoudi NM, Baghlaf KK, Elashiry EA, Farsi NM, El Derwi DA, Bayoumi AM. The effectiveness of computerized anesthesia in primary mandibular molar pulpotomy: a randomized controlled trial. Quintessence International. 2016; 47: 217–224.

[30] Carugo N, Paglia L, Re D. Pain perception using a computer-controlled anaesthetic delivery system in paediatric dentistry: a review. European Journal of Paediatric Dentistry. 2020; 21: 180–182.

[31] Saloum FS, Baumgartner JC, Marshall G, Tinkle J. A clinical comparison of pain perception to the wand and a traditional syringe. Oral Surgery, Oral Medicine, Oral Pathology, and Oral Radiology. 2000; 89: 691–695.