Injection PainNCT07279285
Sweet-Tasting Solution Versus Placebo to Reduce Pain During Local Anesthetic Injection in Children
A study testing Sugar-free-flavored sweet tasting solution in people with Injection Pain and Local Anesthesia Infiltration, run by University of Jordan at 1 site in Jordan.
Trial summary
The goal of this clinical trial is to learn whether applying a sugar-free flavored sweet solution (SFSS) before local anesthesia helps reduce injection pain in children. The main question it aims to answer is: Does SFSS reduce pain during dental local anesthesia compared to a placebo (plain water)? Researchers will… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Injection Pain, Local Anesthesia Infiltration, Pain
- What is being tested?
- Sugar-free-flavored sweet tasting solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteJordan
- Study dates
- 1 Jan 2026to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children who are 6-12 years of age.
- Children classified as ASA1 according to the American Society of Anesthesiologists.
- Children who have positive (Class III) or definitely positive (Class IV) behavior during preoperative behavioral assessments according to the Frankl Scale.
- Children who required bilateral local anesthesia infiltration injections on primary or permanent teeth either in the maxilla or mandible for dental treatment (different types of restoration, stainless steel crowns, pulp therapy, and extractions).
- Children with positive consent forms (signed and approved by their parents/ legal guardians) and attended the appointment.
Who cannot join
- Children who had a history of unpleasant experiences in dental settings.
- Children who had a history of unpleasant experience with local anesthesia injection.
- The presence of medically or developmentally compromising conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Sugar-free-flavored-sweet-tasting-solution on Pain Associated With Dental Injections in Pediatric Patients
The goal of this clinical trial is to learn whether applying a sugar-free flavored sweet solution (SFSS) before local anesthesia helps reduce injection pain in children.
The main question it aims to answer is:
Does SFSS reduce pain during dental local anesthesia compared to a placebo (plain water)? Researchers will compare the use of SFSS and a placebo to see which results in lower pain scores.
Participants will:
Receive SFSS or placebo before local anesthesia during two dental visits Have their pain measured using self-reported and observational pain scales Have their heart rate monitored during the procedure
- Conditions
- Injection Pain, Local Anesthesia Infiltration, Pain, Injection Pain Prevention, Pediatric Patients
- Being tested
- Sugar-free-flavored sweet tasting solution, Placebo (sterile-water)
- Keywords
- clinical trial, sugar-free solution, local anesthesia pain, dental pain, injection pain, children dental pain, split-mouth, sugar-free flavored sweet tasting solution, SFSS, dental fear reduction, dental fear, dental anxiety
- Medical subject headings
- Pain, Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugar-free-flavored sweet tasting solutionOther
A sugar-free-flavored sweet tasting solution that is anticipated to reduce the pain of local anaesthesia injections
Placebo (sterile-water)Other
Placebo (sterile water)
| Study group | Role | What they receive |
|---|---|---|
| Sugar-free-flavored sweet tasting solution Group | Active comparator | Not described Receives: Other: Sugar-free-flavored sweet tasting solution |
| Placebo Group | Placebo comparator | Not described Receives: Other: Placebo (sterile-water) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported pain using faces pain scale-revised (FPS-r)
Pain intensity measured using the Faces Pain Scale - Revised (FPS-R), ranging from 0 to 10, where higher scores indicate greater pain.
Measured: Immediately after local anesthetic injection
Observer-reported pain using Revised Face, Legs, Activity, Cry, Consolability Scale
Pain behavior measured using the Face, Legs, Activity, Cry, Consolability - Revised (FLACC-R) Scale, scored from 0 to 10, where higher scores indicate greater pain-related distress.
Measured: During administration of the local anesthetic injection
Physiological-Heart Rate
Changes in heart rate measured in beats per minute (bpm); increases in heart rate indicate higher physiological arousal associated with pain
Measured: Baseline and During Injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start1 Jan 2026
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injection PainStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamis D. Rajab, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279285
- Sponsor's protocol ID
- UJordanLamis
- Status last verified
- Apr 2026
- First submitted
- 18 Nov 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Sugar-free-flavored-sweet-tasting-solution on Pain Associated With Dental Injections in Pediatric Patients
- ClinicalTrials.gov ID
- NCT07279285
- Acronym / sponsor ID
- UJordanLamis
- Conditions
- Injection Pain, Local Anesthesia Infiltration, Pain, Injection Pain Prevention, Pediatric Patients
- Keywords
- clinical trial, sugar-free solution, local anesthesia pain, dental pain, injection pain, children dental pain, split-mouth, sugar-free flavored sweet tasting solution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 12 Dec 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 goal of this clinical trial is to learn whether applying a sugar-free flavored sweet solution (SFSS) before local anesthesia helps reduce injection pain in children.
The main question it aims to answer is:
Does SFSS reduce pain during dental local anesthesia compared to a placebo (plain water)? Researchers will compare the use of SFSS and a placebo to see which results in lower pain scores.
Participants will:
Receive SFSS or placebo before local anesthesia during two dental visits Have their pain measured using self-reported and observational pain scales Have their heart rate monitored during the procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar-free-flavored sweet tasting solution Group | Active comparator | Other: Sugar-free-flavored sweet tasting solution |
| Placebo Group | Placebo comparator | Other: Placebo (sterile-water) |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children who are 6-12 years of age.
- Children classified as ASA1 according to the American Society of Anesthesiologists.
- Children who have positive (Class III) or definitely positive (Class IV) behavior during preoperative behavioral assessments according to the Frankl Scale.
- Children who required bilateral local anesthesia infiltration injections on primary or permanent teeth either in the maxilla or mandible for dental treatment (different types of restoration, stainless steel crowns, pulp therapy, and extractions).
- Children with positive consent forms (signed and approved by their parents/ legal guardians) and attended the appointment.
Key exclusion criteria (3 listed)
- Children who had a history of unpleasant experiences in dental settings.
- Children who had a history of unpleasant experience with local anesthesia injection.
- The presence of medically or developmentally compromising conditions.
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 |
|---|---|---|
| Sugar-free-flavored sweet tasting solutionA sugar-free-flavored sweet tasting solution that is anticipated to reduce the pain of local anaesthesia injections | Other | Sugar-free-flavored sweet tasting solution Group |
| Placebo (sterile-water)Placebo (sterile water) | Other | Placebo Group |
Primary outcome
Self-reported pain using faces pain scale-revised (FPS-r)
Time frame: Immediately after local anesthetic injection
Pain intensity measured using the Faces Pain Scale - Revised (FPS-R), ranging from 0 to 10, where higher scores indicate greater pain.
Observer-reported pain using Revised Face, Legs, Activity, Cry, Consolability Scale
Time frame: During administration of the local anesthetic injection
Pain behavior measured using the Face, Legs, Activity, Cry, Consolability - Revised (FLACC-R) Scale, scored from 0 to 10, where higher scores indicate greater pain-related distress.
Physiological-Heart Rate
Time frame: Baseline and During Injection
Changes in heart rate measured in beats per minute (bpm); increases in heart rate indicate higher physiological arousal associated with pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugar-free-flavored sweet tasting solution in people with Injection Pain and Local Anesthesia Infiltration, run by University of Jordan at 1 site in Jordan.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 6 May 2026. 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 Jordan. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Self-reported pain using faces pain scale-revised (FPS-r) (time frame: Immediately after local anesthetic injection). The study lists 3 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 6 May 2026.