The Effect of Needle-free Injection System During Palatal Anesthesia

Okan University48 enrolled

Overview

Needle-free injection systems can contribute to the prevention of needle-related pain during palatal infiltration anesthesia (PIA) in children. Research with this topic on children is required.The purpose of this clinical study was to evaluate the effectiveness of the needle-free system versus traditional anesthesia on pain perception during PIA in children.The study was designed as a randomized, controlled cross-over clinical study with 48 children aged 6 to 12 years requiring dental treatment with PIA in bilateral maxillary primary molars. It has been revealed that the application of a needle-free system during PIA ensured a decrease in pain perception in children.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pediatric Anesthesia Local Anesthesia

Interventions

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * In need of treatment of right and left primary molar teeth of maxilla, * Does not have any systemic disorder, * High level of communication that can provide logical answers to the questions we ask * With parental consent, * Volunteers who want to participate in the research * 6-12 years old patients who are compatible with routine dental treatments in the pediatric clinic Exclusion Criteria: * No need for treatment of right and left primary molar teeth of maxilla, * Has a systemic condition * Low level of communication that cannot provide reasonable answers to the questions we ask * Without parental consent * Do not want to participate voluntarily in the research * Do not attend a check-in * Patients not in the 6-12 age group

Outcomes

Primary Outcomes

Wong-Baker Faces Pain Rating Scale (PRS)

The PRS measures the unpleasantness or affective dimension of a child's pain experience and is used in children aged 3-17 years old. The PRS consists of a set of cartoon faces with varying facial expressions ranging from a smile/laughter to tears, and each child is asked to select the facial expression that best represents his/her experience of discomfort. Each face has a numerical value ranging from 0 (smiling face, "no hurt") to 5 (crying/screaming face, "hurts worst").

Time frame: 3 months

Face, Legg, Cry, Consolability Scale (FLACC)

The scale comprised the following parameters: (1) Face, (2) Legs, (3) Activity, (4) Cry, and (5) Consolability. Each of the five categories is scored from 0-2, which results in a minimum total score of 0 and maximumof 10. According to this scale: 0=Relaxed and comfortable (no pain); 1-3=Mild discomfort; 4-6=Moderate pain; and 7-10=Severe discomfort or pain \[Willis et al., 2003\]. Behavioural parameters were recorded.