Effect of a Candy Flavoring Before Local Anesthesia on Anxiety and Pain Perception in Children

Local Anesthesia Clinical Trial

Official title: The Effect of Using a Sugar-free Candy Flavoring Before Local Anesthesia Injection on Anxiety and Pain Perception in Children: a Split-mouth Randomized Clinical Trial

Status Completed

Clinical Trial Summary

This is a randomized clinical trial that aims to test the effect of using sugar-free flavors as a sensory distraction technique during local anesthesia on pain perception and anxiety when compared to negative control group. We expect that using the flavor before injecting local anesthesia will distract the child and reduce pain and anxiety.

Clinical Trial Description

Background: Distraction techniques can be very useful in managing children on the dental chair and to guide their attention away from a painful stimulus. No studies so far have used a sugar-free solution as a distraction method. Aim: To test the effect of using sugar-free flavors as a sensory distraction technique during local anesthesia on pain perception and anxiety when compared to negative control group, using a split-mouth randomized study design. Methods: A total of 84 children, aged 4-10 years with no previous dental experience and require the same treatment on the upper primary first or second molars bilaterally will be included in this study. Each child will receive two injections. The children will be randomly allocated into two groups, group 1 will receive the first injection after applying a flavor, and group 2 will receive the first injection after applying sterile water. The children will receive the first injection either on the right or left side, and switch sides on the next visit, resulting in (n=168) total injections. The observed pain perception will be assessed using the SEM scale. Wong-Baker Faces pain rating scale will be used to assess the pain reported by the child. Pulse rate, BMI, and sweet taste preference will also be recorded by an independent observer to ensure blinding. Expected results: Using a sugar-free candy flavor before injecting local anesthesia will distract the child and reduce pain and anxiety accompanying local anesthesia. ;

Related Conditions & MeSH terms

• Local Anesthesia

• NCT number: NCT05727527
• Study type: Interventional
• Source: King Abdullah University Hospital
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Completion date: September 1, 2023