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

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

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 Overview

• Status: Recruiting
• Conditions: Dental Anesthesia; Pain and Anxiety; Behavioral Management; Sweet Taste Perception
• Intervention / Treatment: Behavioral: Dental anesthesia

• Study Type: Interventional
• Enrollment (Estimated): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El Sherouk
    • Cairo, El Sherouk, Egypt
      • Recruiting
      • Faculty of Dentistry, British University in Egypt
      • Contact: Nada M Farouk, post graduate student; Phone Number: +21020668262; Email: pg.nada92243007@bue.edu.eg
      • Contact: Ola A Abd El-geleel, Associate Professor; Phone Number: +21006086830; Email: ola@dent.asu.edu.eg
      • Sub-Investigator: Noha S Kabil, professor
      • Principal Investigator: Nada M Farouk, bachelors degree
      • Sub-Investigator: Ola A Abd El-Geleel, associate professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Precooling group	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.
Experimental: Precooling + topical anaesthesia group	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.
Experimental: Precooling + sweet tasting solution group	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.
Experimental: Precooling + sweet tasting solution + topical anaesthesia	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.
Experimental: Sweet tasting solution group	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.
Experimental: Sweet tasting solution + topical anaesthesia group	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.
Active Comparator: Topical anaesthesia group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	Pain Intensity assessed by visual analogue scale	Immediately after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1 outcome	The preferred sweet tasting solution based on number of patients	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	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.	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.	Immediately before needle injection (baseline), during needle injection, and immediately after completion of injection. Recorded as percentage

Collaborators and Investigators

• Sponsor: British University In Egypt

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: September 7, 2026
• First Submitted That Met QC Criteria: September 16, 2026
• First Posted (Actual): September 22, 2026

Study Record Updates

• Last Update Posted (Actual): September 22, 2026
• Last Update Submitted That Met QC Criteria: September 16, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Anxiety Disorders; Anesthesia and Analgesia; Anesthesia; Dentistry; Anesthesia, Dental
• Other Study ID Numbers: 24-028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No