Effects of Topical Anesthetics on Pain and Anxiety in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Dental Anxiety, Children. Basic parameters: 6 years — 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of the Effects of Different Topical Anesthetic Agents on Pain and Anxiety in Pediatric Patients
Overview
Dental anxiety and pain associated with local anesthetic injections are among the most common barriers to successful dental treatment in children. Topical anesthetic agents are widely used to reduce discomfort during needle insertion; however, evidence regarding the comparative effectiveness of different formulations remains limited. This prospective observational study aims to evaluate the effects of four routinely used topical anesthetic applications (benzocaine spray, benzocaine gel, lidocaine spray, and lidocaine gel) on pain and anxiety during local infiltration anesthesia in pediatric dental patients. The study will include 160 healthy children aged 6-8 years who require maxillary infiltration anesthesia for routine dental treatment. The choice of topical anesthetic will be determined by the treating clinician as part of routine clinical practice, and no additional intervention or treatment modification will be performed for research purposes. Dental anxiety will be assessed using the Modified Child Dental Anxiety Scale-faces version (MCDASf), behavioral responses during local anesthetic administration will be evaluated using the Sound, Eye, and Motor (SEM) scale, and self-reported pain will be measured using the Wong-Baker FACES Pain Rating Scale. Physiological parameters, including heart rate, blood pressure, peripheral oxygen saturation (SpO₂), and body temperature, will be recorded before, during, and after local anesthetic administration. The findings are expected to provide evidence regarding the effectiveness of commonly used topical anesthetic formulations in reducing pain and anxiety during pediatric dental treatment and may contribute to optimizing behavior management strategies in clinical practice.
Primary outcome measures
- Dental Anxiety Score (MCDASf) [Time frame: Baseline (T0) and immediately after local anesthetic administration (T2)]
- Pain During Local Anesthetic Administration [Time frame: Immediately after local anesthetic administration (T2)]
- Behavioral Response During Local Anesthetic Administration [Time frame: During local anesthetic administration (T1)]
Secondary outcome measures (4)
- Heart Rate [Time frame: Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2)]
- Blood Pressure [Time frame: Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2)]
- Peripheral Oxygen Saturation (SpO₂) [Time frame: Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2)]
- Body Temperature [Time frame: Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2)]
Eligibility criteria
Inclusion criteria
- Children aged 6 to 8 years.
- Frankl Behavior Rating Scale score of 3 or 4.
- No previous history of local anesthetic injection for dental treatment.
- Requiring maxillary infiltration anesthesia for treatment of a maxillary second primary molar.
- Requiring non-emergency, painless dental treatment.
- Medically healthy children with no chronic systemic disease, mental disability, or physical disability.
- Written informed consent obtained from a parent or legal guardian.
Exclusion criteria
- Frankl Behavior Rating Scale score of 1 or 2.
- Physical or intellectual disability.
- History of cardiovascular disease, diabetes mellitus, Graves' disease, epilepsy, hyperthyroidism, active infection, phenylketonuria, cardiovascular shock, otorrhea, or otitis.
- Known hypersensitivity or allergy to benzocaine, lidocaine, or any component of the topical anesthetic formulations.
- Emergency dental treatment or presence of dental pain requiring urgent intervention.
- Chronic liver or kidney disease.
- History of methemoglobinemia.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07733622 · 2026/300