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

NCT07835191 · tracked via the Priya Life Science Egypt tracker

Sponsor

British University In Egypt

Phase

Not applicable

Started

2025-10-06

Last updated

2026-09-22

Condition(s) studied

Dental AnesthesiaSweet Taste PerceptionPain and AnxietyBehavioral Management

Investigational drug(s) / intervention(s)

Dental anesthesia

Dental anesthesia: The intervention consists of pre-cooling and/or a sweet-tasting solution, used alone or in combination with topical local anesthesia, before administration of the dental local anesthetic injection.

Study summary

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.

Eligibility

Sex

ALL

Min age

7 Years

Max age

11 Years

Healthy volunteers

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

Primary outcome measure(s)

Visual Analog Scale (VAS) — Immediately after intervention
Pain Intensity assessed by visual analogue scale

Trial sites (1)

Facility	City	Region	Status
Faculty of Dentistry, British University in Egypt	Cairo	El Sherouk	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07835191 on ClinicalTrials.gov ↗ ← All trials in Egypt