PainNCT07002528
The Effectiveness of Sweet Solution Versus Cryotherapy in Reducing Pain During Administration of Local Anesthesia Among Children
A study testing sucrose solution, Cryotherapy and topical anesthesia in people with Pain, run by Mansoura University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- sucrose solution, Cryotherapy and topical anesthesia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 2 May 2024to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Pain
- Being tested
- sucrose solution, Cryotherapy, topical anesthesia
- Keywords
- Dental pain, Anesthesia, Sucrose, Cryotherapy, Topical anesthesia
- Medical subject headings
- Pain, Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sucrose solutionBehavioural
apply sucrose solution to evaluate pain among local anesthesia
CryotherapyBehavioural
apply cryotheraby to evaluate pain among local anesthesia
topical anesthesiaBehavioural
apply topical anesthesia to evaluate pain among local anesthesia
| Study group | Role | What they receive |
|---|---|---|
| apply treatment with sucrose solution as analgesic before admenistration of local anesthesia | Experimental | Not described Receives: Behavioral: sucrose solution |
| apply treatment with cryotherapy as analgesic before admenistration of local anesthesia | Experimental | Not described Receives: Behavioral: Cryotherapy |
| apply normal treatment with topical anesthesia before admenistration of local anesthesia | Experimental | Not described Receives: Behavioral: topical anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to twelve weeks
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
Measured: up to twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start2 May 2024
- Primary completion28 May 2025
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manwa Ayed, Mansoura University
- Investigators
- Manwa Ahmed Ayed, Master, Study chair, Researcher of Pediatric Dentistry Faculty of Dentistry Mansoura UniversitySalwa M Awad, prof, Study director, Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura UniversityAhmed Hamdy Wahba, Assistant professor, Study director, assistant Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002528
- Sponsor's protocol ID
- ِA0203024PP
- Status last verified
- Aug 2025
- First submitted
- 25 May 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol to other researcher
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Sweet Solution Versus Cryotherapy in Reducing Pain During Administration of Local Anesthesia Among Children
- ClinicalTrials.gov ID
- NCT07002528
- Acronym / sponsor ID
- ِA0203024PP
- Conditions
- Pain
- Keywords
- Dental pain, Anesthesia, Sucrose, Cryotherapy, Topical anesthesia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sucrose solutionapply sucrose solution to evaluate pain among local anesthesia | Behavioural | apply treatment with sucrose solution as analgesic before admenistration of local anesthesia |
| Cryotherapyapply cryotheraby to evaluate pain among local anesthesia | Behavioural | apply treatment with cryotherapy as analgesic before admenistration of local anesthesia |
| topical anesthesiaapply topical anesthesia to evaluate pain among local anesthesia | Behavioural | apply normal treatment with topical anesthesia before admenistration of local anesthesia |
Primary outcome
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: Yes. Study protocol to other researcher
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sucrose solution, Cryotherapy and topical anesthesia in people with Pain, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (time frame: up to twelve weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.