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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07002528
Enrollment
180
Registered
2025-06-03
Start date
2024-05-02
Completion date
2025-08-15
Last updated
2025-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Dental pain, Anesthesia, Sucrose, Cryotherapy, Topical anesthesia

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

Interventions

apply sucrose solution to evaluate pain among local anesthesia

BEHAVIORALCryotherapy

apply cryotheraby to evaluate pain among local anesthesia

apply topical anesthesia to evaluate pain among local anesthesia

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
7 Years to 11 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
VASup to twelve weeksa 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 scaleup to twelve weeksa 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026