CClinicalTrials.gg
Active, not recruitingNCT07002528Updated Aug 26, 2025

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

An interventional study of sucrose solution and Cryotherapy in Pain, sponsored by Mansoura University. Active, not recruiting at 1 site in Egypt. Open to participants aged 7 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-26.

Sponsored by Mansoura University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
7 Years to 11 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Pain

Browse trials for

Keywords

  • Dental pain
  • Anesthesia
  • Sucrose
  • Cryotherapy
  • Topical anesthesia
03

Who can participate

Ages eligible
7 Years to 11 Years
Sexes eligible
All
Accepts 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

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.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (actual)

Study arms

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

    Behavioral: sucrose solution

  • Experimental
    apply treatment with cryotherapy as analgesic before admenistration of local anesthesia

    Behavioral: Cryotherapy

  • Experimental
    apply normal treatment with topical anesthesia before admenistration of local anesthesia

    Behavioral: topical anesthesia

Interventions

  • Behavioralsucrose solution

    apply sucrose solution to evaluate pain among local anesthesia

  • BehavioralCryotherapy

    apply cryotheraby to evaluate pain among local anesthesia

  • Behavioraltopical anesthesia

    apply topical anesthesia to evaluate pain among local anesthesia

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to twelve weeks

  2. 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

    Time frame: up to twelve weeks

06

Study locations

1 site
  • Mansoura university
    Al Mansurah, Dakahilia 35511, Egypt
07

References and documents

Individual participant data

Plan to share: Yes — Study protocol to other researcher

Supporting information: Study protocol

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07002528
Lead sponsor
Mansoura University
Responsible party
Manwa Ayed (Principal Investigator, Mansoura University) — Principal investigator
First posted
Jun 3, 2025
Start date
May 2, 2024
Primary completion
May 28, 2025
Completion
Aug 15, 2025 (estimated)
Last update
Aug 26, 2025

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion