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Effectiveness of Three Pre-Anesthetic Surface Treatments in Reducing Pain and Anxiety During Local Anesthesia Injections in Children- A Randomized crossover study

Effectiveness of Three Pre-Anesthetic Surface Treatments in Reducing Pain and Anxiety During Local Anesthesia Injections in Children: A Randomized crossover study - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/090416
Enrollment
24
Registered
2025-07-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K040- Pulpitis

Interventions

Intervention1: Cryotherapy : Application of an ice cube at the injection site for about 30 seconds before administering local anesthesia to reduce pain via nerve desensitization and vasoconstriction.

Sponsors

Poonam Shukla
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Requiring buccal infiltration anesthesia for dental treatment. 2. Requiring multiple dental appointments. 3. Classified as negative or positive on the Frankl Behavior Rating Scale (Annexure1). 4. Free of allergies to topical anesthetics used in the study. 5. Free from neurological or psychological disorders. 6. Parents provide informed consent, and children above 7 years provide assent.

Exclusion criteria

Exclusion criteria: 1. Children classified as definitely negative or definitely positive on the Frankl Behavior Rating Scale. 2. Patients where local anesthesia is contraindicated. 3. Children with special healthcare needs. 4. Patients unable to follow instructions due to psychological or developmental impairments. 5. Patients who decline to participate.

Design outcomes

Primary

MeasureTime frame
Pain perception during local anesthesia injection (measured by VAS, Wong-Baker Faces). Anxiety levels before and after injection (measured by Venham s Picture Scale). Timepoint: at baseline, after 10 days then again after 10 days

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactPOONAM SHUKLA

KING GEORGE MEDICAL COLLEGE

rajeevkumarsingh@kgmcindia.edu9450849528

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026