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RecruitingNCT07835191Updated Sep 22, 2026

Efficacy of Pre-cooling and Sweet-tasting Solution on Pain Related to Local Anesthesia Injection in Children

An interventional study of Dental anesthesia in Dental Anesthesia, Sweet Taste Perception and Pain and Anxiety, sponsored by British University In Egypt. Recruiting at 1 site in Egypt. Open to participants aged 7 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by British University In Egypt · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Oct 2025, registered Sep 2026).
  • Started Oct 2025; still recruiting 1 year 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
224
Allocation
Randomized
Ages
7 Years to 11 Years
Sex
All
01

Study summary

The study aims to determine whether pre-cooling and sweet-tasting solutions, alone or combined with topical anesthesia, provide better pain control during dental local anesthesia in children.

It has two phases:

Phase 1: Identify the children's preferred sweet-tasting solution among xylitol, monk fruit, erythritol, and honey.

Phase 2: A randomized controlled trial comparing 7 groups involving pre-cooling, sweet solution, topical anesthesia, and their combinations.

The primary outcome is pain measured by VAS, while secondary outcomes include SEM behavioral response, heart rate, and oxygen saturation. The planned sample is 220 children.

02

Conditions studied

  • Dental Anesthesia
  • Sweet Taste Perception
  • Pain and Anxiety
  • Behavioral Management
03

In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's planned enrollment of 224 is above the median of 66 across 8,493 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

British University In Egypt is the lead sponsor of 70 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age group 7-11 years
  2. Patients requiring infiltration anesthesia to fulfill dental therapeutic needs
  3. Frankl behavior scale 3 and 4

Exclusion criteria

Exclusion Criteria:

  1. Failure to provide assent or consent
  2. Allergy from local anesthetic solution
  3. Systemic diseases such as diabetes that could affect pain perception
  4. History of abscess or fistula at site of injection
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
224 participants (estimated)

Study arms

  • Experimental
    Precooling group

    Behavioral: Dental anesthesia

  • Experimental
    Precooling + topical anaesthesia group

    Behavioral: Dental anesthesia

  • Experimental
    Precooling + sweet tasting solution group

    Behavioral: Dental anesthesia

  • Experimental
    Precooling + sweet tasting solution + topical anaesthesia

    Behavioral: Dental anesthesia

  • Experimental
    Sweet tasting solution group

    Behavioral: Dental anesthesia

  • Experimental
    Sweet tasting solution + topical anaesthesia group

    Behavioral: Dental anesthesia

  • Active comparator
    Topical anaesthesia group

    Behavioral: Dental anesthesia

Interventions

  • BehavioralDental anesthesia

    The intervention consists of pre-cooling and/or a sweet-tasting solution, used alone or in combination with topical local anesthesia, before administration of the dental local anesthetic injection.

06

What researchers measure

Primary outcomes

  1. Visual Analog Scale (VAS)

    Pain Intensity assessed by visual analogue scale

    Time frame: Immediately after intervention

Secondary outcomes

  1. Phase 1 outcome

    The preferred sweet tasting solution based on number of patients

    Time frame: After intervention

  2. Heart Rate

    Heart rate (beats per minute) measured immediately before needle insertion (baseline) and the maximum heart rate recorded during needle injection and after needle injection

    Time frame: Heart rate (beats per minute) measured immediately before needle insertion (baseline) and during needle injection and after needle injection

  3. Sound, eye and motor scale (SEM) scale

    Behavioral pain response during local anesthetic injection assessed using the Sound, Eye, and Motor (SEM) Scale. Sound, eye, and motor responses are each scored from 1 to 4, with 1 indicating comfort and 4 indicating a painful response. The three component scores are summed to obtain a total SEM score ranging from 3 to 12, with higher scores indicating greater behavioral response to pain.

    Time frame: During needle injection

  4. Oxygen saturation

    Peripheral oxygen saturation (SpO₂) will be measured using a pulse oximeter and recorded as a percentage at three time points: immediately before local anesthetic needle injection (baseline), during needle injection, and immediately after completion of the injection.

    Time frame: Immediately before needle injection (baseline), during needle injection, and immediately after completion of injection. Recorded as percentage

07

Study locations

1 of 1 sites recruiting
  • Faculty of Dentistry, British University in Egypt
    Cairo, El Sherouk, Egypt
    Recruiting
    • Nada M Farouk, post graduate student · Contactpg.nada92243007@bue.edu.eg · +21020668262
    • Ola A Abd El-geleel, Associate Professor · Contactola@dent.asu.edu.eg · +21006086830
    • Noha S Kabil, professor · Sub investigator
    • Nada M Farouk, bachelors degree · Principal investigator
    • Ola A Abd El-Geleel, associate professor · Sub investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for Jan 2027, 15 months after the start.

Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 15 months is above that.

Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 7, 2026
First posted
Sep 22, 2026
StartActual
Oct 6, 2025
Primary completionEst.
Jan 2027
CompletionEst.
Apr 2027
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07835191
Lead sponsor
British University In Egypt
Responsible party
Nada Mohammed Farouk (Principal investigator, British University In Egypt) — Principal investigator
First posted
Sep 22, 2026
Start date
Oct 6, 2025
Primary completion
Jan 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Sep 22, 2026

Oversight

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

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No contact was published for this record. The registry link below has the sponsor’s details.

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