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

NCT07002528 — Not applicable, Active not recruiting, 180 participants, Mansoura University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT07002528
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, other
Enrollment	180 (Actual)
Sponsor	Mansoura University (Other)
Conditions	Pain
Interventions	sucrose solution, Cryotherapy, topical anesthesia (Behavioral)
Dates	start 2024-05-02, primary completion 2025-05-28, completion 2025-08-15 (estimated), first posted 2025-06-03, last updated 2025-08-26
Locations	1 site in Egypt

-Summary

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

Expand all sections · Collapse all

+Detailed description

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

+Arms and interventions

Arm	Type	Interventions
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

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

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 7 Years to 11 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Mansoura university	Al Mansurah, Dakahilia	Egypt

+Investigators

Manwa Ahmed Ayed, Master, Study chair, Researcher of Pediatric Dentistry Faculty of Dentistry Mansoura University
Salwa M Awad, prof, Study director, Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura University
Ahmed Hamdy Wahba, Assistant professor, Study director, assistant Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura University