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NCT Number: NCT07002528

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university

Al Mansurah, Dakahilia, 35511, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

sucrose solution

Behavioral

apply sucrose solution to evaluate pain among local anesthesia

Cryotherapy

Behavioral

apply cryotheraby to evaluate pain among local anesthesia

topical anesthesia

Behavioral

apply topical anesthesia to evaluate pain among local anesthesia

Primary outcomes

  1. VAS

    Time frame: up to twelve weeks

    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.

  2. FLACC scale

    Time frame: up to twelve weeks

    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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 3, 2025
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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