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Assessment of the effectiveness, pain perception and adverse effects of warm local anaesthetic solution with the conventional local anaesthetic technique in 7 - 9 years children

A COMPARATIVE EVALUATION OF THE EFFICACY, PAIN PERCEPTION, HEMODYNAMIC CHANGES AND ADVERSE EFFECTS OF WARM LOCAL ANAESTHETIC SOLUTION DELIVERED ON PRE-COOLED INJECTION SITES WITH THE CONVENTIONAL LOCAL ANAESTHETIC TECHNIQUE IN 7 - 9 YEARS CHILDREN: AN IN VIVO RANDOMIZED SPLIT MOUTH CLINICAL TRIAL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036135
Enrollment
70
Registered
2021-09-01
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

None listed

Interventions

Intervention1: Prewarmed 2% Lignocaine solution and iced cube: Administration of pre-warmed local anesthetic solution on pre-cooled injected sites using inferior alveolar nerve block Control Intervent

Sponsors

Megha Chittora
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Medically fit children aged between 7 to 9 years. 2. Children who are mentally capable of communication and those who can follow the instructions and able to interpret the pain perception appropriately. 3. Having mandibular primary molar tooth that require extraction or pulp therapy bilaterally or requiring at least two clinical sessions of pulp therapy procedures. 4. Requiring bilateral inferior alveolar nerve block, without any history of receiving dental injections. 5. Children, who are cooperative enough to undergo dental procedures 6. Parental informed written consent provided 7. Tooth which will give a baseline reading on pulp tester before administration of local anesthetic.

Exclusion criteria

Exclusion criteria: 1. Patients with acute signs and symptoms requiring emergency treatment, with previous painful dental experience, and who were medically compromised were excluded from the study 2. History of any post-traumatic stress disorders or specific phobia related to dental settings. 3. History of systemic mental or physical disorders. 4. Children with allergic reactions to lidocaine. 5. Children with cold hypersensitivity and underlying vascular or immunological diseases were excluded from the study.

Design outcomes

Primary

MeasureTime frame
Administration of warm local anaesthetic solution on pre-cooled injection sites may create reduction in pain perception and may provide better anesthesia in children when compared to conventional local anaesthetic technique during inferior alveolar nerve block anesthesia Timepoint: Immediately after administration of local anesthesia

Secondary

MeasureTime frame
Administration of warm local anaesthetic solution on pre-cooled injection sites may provide less adverse effects and hemodynamic changes when compared to conventional local anesthetic techniqueTimepoint: Hemodynamic changes will be evaluated immediately at the time of administration of local anesthesia and adverse effects will be evaluated after 24 hours

Countries

India

Contacts

Public ContactMegha Chittora

Pacific Dental College and Hospital

pedodinesh2003@gmail.com9414158235

Outcome results

None listed

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