The Effectiveness of Sweet Solution Versus Cryotherapy in Reducing Pain During Administration of Local Anesthesia Among Children

NCT07002528 | Active Not Recruiting

• 1 other identifier: ِA0203024PP
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

the porpose of study to assess The Effectiveness of Sweet Solution Versus Cryotherapy in Reducing Pain During Administration of Local Anesthesia Among Children

Conditions

Pain

Keywords

Dental pain; Anesthesia; Sucrose; Cryotherapy; Topical anesthesia

Outcome Measures

Primary Outcomes (2)

• VAS

  a simple, 10-cm line used to measure pain intensity in children, with word anchors at each end like "no pain" and "worst possible pain". Children are asked to mark the point on the line that represents their pain level, and the distance from the "no pain" anchor is used to calculate the score. While VAS is generally considered reliable for children 5 years and older, some studies suggest younger children may struggle with the conceptual complexity.

  up to twelve weeks

• FLACC scale

  a behavioral pain assessment tool used for children, especially those who cannot verbally express their pain. It stands for Face, Legs, Activity, Cry, and Consolability. The FLACC scale is used to assess pain in infants and children from birth and older, including those with developmental delays. It's a way to understand pain by observing facial expressions and behavioral patterns. Each of the five categories is scored on a 0-2 scale, resulting in a total pain score from 0 to 10

  up to twelve weeks

Study Arms (3)

apply treatment with sucrose solution as analgesic before admenistration of local anesthesia

EXPERIMENTAL

Behavioral: sucrose solution

apply treatment with cryotherapy as analgesic before admenistration of local anesthesia

EXPERIMENTAL

Behavioral: Cryotherapy

apply normal treatment with topical anesthesia before admenistration of local anesthesia

EXPERIMENTAL

Behavioral: topical anesthesia

Interventions

sucrose solution BEHAVIORAL

apply sucrose solution to evaluate pain among local anesthesia

apply treatment with sucrose solution as analgesic before admenistration of local anesthesia

Cryotherapy BEHAVIORAL

apply cryotheraby to evaluate pain among local anesthesia

apply treatment with cryotherapy as analgesic before admenistration of local anesthesia

topical anesthesia BEHAVIORAL

apply topical anesthesia to evaluate pain among local anesthesia

apply normal treatment with topical anesthesia before admenistration of local anesthesia

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children with behavior rating score 2,3 or 4 of Frankl's behavior rating scale
• children aged 6-11 years requiring dental injections for pulpectomy, root canal treatment, or extraction procedures for primary and permanent mandibular molars.

You may not qualify if:

• Allergy to lidocaine
• Redness at the site of injection؛ and a history of abscess, sinus tract, or fistula associated with the teeth.
• Children with special health care needs.
• Children suffering from systemic diseases.
• Extremely uncooperative children.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university

Al Mansurah, Dakahilia, 35511, Egypt

Location

MeSH Terms

Conditions

Pain; Toothache

Interventions

sodium lactobionate sucrose solution; Cryotherapy; Anesthesia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tooth Diseases; Stomatognathic Diseases; Facial Pain

Intervention Hierarchy (Ancestors)

Therapeutics; Anesthesia and Analgesia

Study Officials

• Manwa Ahmed Ayed, Master

  Researcher of Pediatric Dentistry Faculty of Dentistry Mansoura University

  STUDY CHAIR

• Salwa M Awad, prof

  Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura University

  STUDY DIRECTOR

• Ahmed Hamdy Wahba, Assistant professor

  assistant Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Selected children will be divided randomly into 3 groups: Sucrose group (Group I). Cryotherapy group (Group II). Control group topical anesthesia (Group III).

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 3, 2025
• Study Start: May 2, 2024
• Primary Completion: May 28, 2025
• Study Completion: August 15, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: within 6 month
• Access Criteria: for any one

Locations

EG (1)