Comparison of a Neuromodulation Device and Topical Anesthetic for Reducing Pain and anxiety Before Local Anesthesia in Children

Comparative evaluation of the effectiveness of a neuromodulation device and conventional topical anesthetic agent prior to local anesthesia administration in children: A randomised controlled clinical trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/082415

Enrollment

Registered

2025-03-17

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Health Condition 1: K049- Other and unspecified diseases ofpulp and periapical tissues

Interventions

Intervention1: Neuromodulation Device: A wet cotton will be used at the site of needle insertion to mimic lignocaine jelly application. Synapse dental pain eraser will be used for 40 seconds at the si

Eligibility

Inclusion criteria

Inclusion criteria: 1- Patients in ASA-I and ASA-II category. 2- Patients who are indicated for primary teeth extraction. 3- Patients in the 6-10 yrs of age group. 4- Children with Frankel Behaviour ratings 3 and 4.

Exclusion criteria

Exclusion criteria: 1- Patients with known allergy to any component of local anesthesia. 2- Patients with special health care needs 3- Patients unwilling to be a part of this study

Design outcomes

Primary

Measure	Time frame
Assessment of pain and anxiety in child will be measured using- Wong-Baker Faces Pain Rating Scale (WBFPRS), FLACC Scale (Face, Legs, Activity, Cry, Consolability) Pain Assessment Tool, Salivary pH (collected from unstimulated saliva by drooling method), Pulse rate (using a pulse oximeter), and Respiratory Rate (analyzed manually) Timepoint: At baseline, during needle insertion and local anesthesia deposition	—

Measure

Time frame

Assessment of pain and anxiety in child will be measured using- Wong-Baker Faces Pain Rating Scale (WBFPRS), FLACC Scale (Face, Legs, Activity, Cry, Consolability) Pain Assessment Tool, Salivary pH (collected from unstimulated saliva by drooling method), Pulse rate (using a pulse oximeter), and Respiratory Rate (analyzed manually) Timepoint: At baseline, during needle insertion and local anesthesia deposition

—

Secondary

Measure	Time frame
Assessment of pain & anxiety in child will be measured using- Wong-Baker Faces Pain Rating Scale (WBFPRS), FLACC Scale (Face, Legs, Activity, Cry, Consolability) Pain Assessment Tool, Salivary pH (collected from unstimulated saliva by drooling method), Pulse rate (using a pulse oximeter), & Respiratory Rate (analyzed manually) Timepoint: At baseline, during needle insertion & local anesthesia deposition	—

Measure

Time frame

Assessment of pain & anxiety in child will be measured using- Wong-Baker Faces Pain Rating Scale (WBFPRS), FLACC Scale (Face, Legs, Activity, Cry, Consolability) Pain Assessment Tool, Salivary pH (collected from unstimulated saliva by drooling method), Pulse rate (using a pulse oximeter), & Respiratory Rate (analyzed manually) Timepoint: At baseline, during needle insertion & local anesthesia deposition

—

Countries

India

Contacts

Public ContactDr ADITYA SAXENA

ITS Dental College Hospital and Research Centre

adisaxen85@gmail.com8527969884

Outcome results

None listed

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