Efficacy of Pre-cooling and Sweet-tasting Solution on Pain Related to Local Anesthesia Injection in Children

British University In Egypt224 enrolled

Overview

The study aims to determine whether pre-cooling and sweet-tasting solutions, alone or combined with topical anesthesia, provide better pain control during dental local anesthesia in children. It has two phases: Phase 1: Identify the children's preferred sweet-tasting solution among xylitol, monk fruit, erythritol, and honey. Phase 2: A randomized controlled trial comparing 7 groups involving pre-cooling, sweet solution, topical anesthesia, and their combinations. The primary outcome is pain measured by VAS, while secondary outcomes include SEM behavioral response, heart rate, and oxygen saturation. The planned sample is 220 children.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

224

Conditions

Dental Anesthesia Sweet Taste Perception Pain and Anxiety Behavioral Management

Eligibility

Sex: ALLMin age: 7 YearsMax age: 11 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age group 7-11 years 2. Patients requiring infiltration anesthesia to fulfill dental therapeutic needs 3. Frankl behavior scale 3 and 4 Exclusion Criteria: 1. Failure to provide assent or consent 2. Allergy from local anesthetic solution 3. Systemic diseases such as diabetes that could affect pain perception 4. History of abscess or fistula at site of injection

Outcomes

Primary Outcomes

Visual Analog Scale (VAS)

Pain Intensity assessed by visual analogue scale

Time frame: Immediately after intervention

Secondary Outcomes

Phase 1 outcome

The preferred sweet tasting solution based on number of patients

Time frame: After intervention

Heart Rate

Heart rate (beats per minute) measured immediately before needle insertion (baseline) and the maximum heart rate recorded during needle injection and after needle injection

Time frame: Heart rate (beats per minute) measured immediately before needle insertion (baseline) and during needle injection and after needle injection

Sound, eye and motor scale (SEM) scale

Behavioral pain response during local anesthetic injection assessed using the Sound, Eye, and Motor (SEM) Scale. Sound, eye, and motor responses are each scored from 1 to 4, with 1 indicating comfort and 4 indicating a painful response. The three component scores are summed to obtain a total SEM score ranging from 3 to 12, with higher scores indicating greater behavioral response to pain.

Time frame: During needle injection

Oxygen saturation

Peripheral oxygen saturation (SpO₂) will be measured using a pulse oximeter and recorded as a percentage at three time points: immediately before local anesthetic needle injection (baseline), during needle injection, and immediately after completion of the injection.

Time frame: Immediately before needle injection (baseline), during needle injection, and immediately after completion of injection. Recorded as percentage