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RECRUITING
NCT07835191
NA

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

Sponsor: British University In Egypt

View on ClinicalTrials.gov

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.

Official title: Efficacy of Pre-cooling and Sweet-tasting Solution on Pain Related to Local Anesthesia Injection in Children: A Randomized Control Trial

Key Details

Gender

All

Age Range

7 Years - 11 Years

Study Type

INTERVENTIONAL

Enrollment

224

Start Date

2025-10-06

Completion Date

2027-04

Last Updated

2026-09-22

Healthy Volunteers

No

Interventions

BEHAVIORAL

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.

Locations (1)

Faculty of Dentistry, British University in Egypt

Cairo, El Sherouk, Egypt