NCT06340022

Pain and Anxiety Levels of Sleeperone Electronic Anesthesia System in Pediatric Patients

Comparison of Pain and Anxiety Levels of Sleeperone 5 Electronic Anesthesia System and Conventional Local Anesthesia Techniques in Pediatric Patients: a Randomised Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Eskisehir Osmangazi University · Academic / Other
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Accepted

Summary

The conventional method used for dental anesthesia in children is the administration of a local anesthetic solution by injection. Although this process successfully eliminates pain during the procedure, it continues to be a problem for many children in terms of dental anxiety before and during anesthesia administration. The aim of this study is to compare intraosseous anesthesia with SleeperOne® 5, a computer-assisted local anesthesia system, with conventional local anesthesia techniques in terms of pain and anxiety.

Detailed description

In the conventional injection technique, painful local swelling of the tissues at the injection site occurs during the administration of local anesthetics. Failure to control the rate of administration of anesthesia increases pain, swelling and tissue tension, leading to the discomfort and unpleasant sensations that accompany local anesthesia. In addition, an uncontrolled and shocking increase in pressure in the anesthetized tissues can lead to short-term blood supply disturbances and local damage, reducing the effectiveness of anesthesia and increasing the risk of side effects. It has been reported that the pain felt during anesthesia is mostly caused by the inability to control the pressure generated during the injection of the solution. To overcome these shortcomings, the search for new alternative and minimally invasive methods of local anesthesia has been in the limelight with better pain control, reduced injection pain and improved quality of treatment for pedodontic procedures. With the use of computer-assisted local anesthesia systems, the anesthetic solution is administered gradually and the tissue pressure during anesthesia can be controlled. Thus, a less painful and more comfortable anesthesia experience can be provided. SleeperOne® 5, one of the computer-assisted local anesthesia systems, is a device with advantages such as ease of use, less intimidating physical appearance of the needle, no need for pressure during injection, guided entry points to the injection site. There are no previous studies comparing the use of intraosseous technique with SleeperOne® 5 device and conventional mandibular anesthesia in mandibular permanent molars. In this study, the investigators aimed to compare the pain and anxiety caused by the SleeperOne® 5 anesthesia system in children compared to traditional anesthesia methods, of which there are few studies in the literature. The first null hypothesis (H0) of the study is that there is no difference between intraosseous anesthesia administered with SleeperOne® 5 computer-assisted anesthesia systems and buccal infiltration and mandibular anesthesia administered with conventional methods in terms of anxiety in patients. The second null hypothesis of the study is that there is no difference between intraosseous anesthesia performed with SleeperOne® 5 computer-assisted anesthesia systems and buccal infiltration and mandibular anesthesia performed with conventional methods in terms of pain.

Conditions

• Dental Anxiety
• Pain

Interventions

Type	Name	Description
OTHER	Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) scale	Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) scale was applied to determine the anxiety level before the procedure.
OTHER	Face Image Scale (FIS) scoring system	Face Image Scale (FIS) scoring system (1= not afraid at all, 2= very little afraid, 3= afraid, 4= quite afraid, 5= very much afraid) was used to determine the anxiety level before starting anesthesia and after the anesthesia.
OTHER	Visual Analogue Scale (VAS)	In the Visual Analogue Scale (VAS), the patient was asked to rate the pain he/she felt during anesthesia on a 10 cm long ruler ranging from no pain=0 to unbearable pain=10.
OTHER	pulse rate	Before starting anesthesia and after the anesthesia the patient's pulse rate was measured and recorded with a pulse oximeter.

Timeline

• Start date: 2023-03-13
• Primary completion: 2023-10-02
• Completion: 2023-11-15
• First posted: 2024-04-01
• Last updated: 2024-04-01

Locations

1 site across 1 country: Turkey (Türkiye)