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

Not Applicable

Active, not recruiting

• Conditions: Pain

• Registration Number: NCT07002528
• Lead Sponsor: Mansoura University

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

Detailed Description

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

Study Timeline

• Study Start: 2024-05-02
• Status Verified: 2025-05
• Study First Submitted: 2025-05-25
• Study First Submitted QC: 2025-05-25
• Last Update Submitted: 2025-05-25
• Primary Completion: 2025-05-28
• Study First Posted: 2025-06-03
• Last Update Posted: 2025-06-03
• Study Completion: 2025-08-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

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

Exclusion criteria:

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
VAS	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.
FLACC scale	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

Trial Locations

Locations (1)

Mansoura university; 🇪🇬 Mansoura, Dakahilia, Egypt