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Clinical Trials/NCT06519838
NCT06519838
Completed
Not Applicable

Effect of Pre-Warming of Local Anesthesia in Reducing Pain Perception During Injection in Children: A Randomized Controlled Clinical Trial

Andrew Emad1 site in 1 country72 target enrollmentJanuary 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Local Anesthesia
Sponsor
Andrew Emad
Enrollment
72
Locations
1
Primary Endpoint
Heart rate (HR) monitoring
Status
Completed
Last Updated
last year

Overview

Brief Summary

The aim of the current study was to evaluate the pain perception upon injection of pre-warmed dental anesthetic solution (at 370C and 400C) versus that at room temperature (Average 23 degrees) during Maxillary Infiltration and Mandibular Inferior Alveolar Nerve Block techniques in children

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
June 10, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Andrew Emad
Responsible Party
Sponsor Investigator
Principal Investigator

Andrew Emad

Pediatric Dentist

Alexandria University

Eligibility Criteria

Inclusion Criteria

  • Healthy patients with ASA 1 or 2 Classification.
  • Patients with Frankl Behavior Classification 3-
  • Patients having at least one carious primary molar that requires dental treatment under the effect of local anesthesia.
  • Parents' willingness to participate through informed written consent.

Exclusion Criteria

  • Patients with previous negative dental experience.
  • Patients complaining of cellulitis or infection spreading in the fascial spaces.
  • Patients who have received analgesics within the previous 12 hours before receiving the required dental treatment.
  • Patients with any Intellectual Impairment.
  • Patients with a history of allergy from any of the components of the dental anesthetic carpule.

Outcomes

Primary Outcomes

Heart rate (HR) monitoring

Time Frame: during local anesthesia administration

A pulse oximeter will be used to record and measure the patient's heart rate. A baseline reading will be obtained before the LA administration and another reading will be obtained directly after the injection is carried out. Heart rate ranging between 70-100 is considered normal.

Pain during injection using Face scale

Time Frame: during local anesthesia administration

To assess pain subjectively during local anesthesia administration, a modified face scale. It consists of three schematic faces with different facial expressions for happy and sad faces representing: 1. Satisfaction 2. Indifference 3. Dissatisfaction Each patient was trained on using the scale by modelling and then requesting from every patient to think of the last time she/he went through a painful experience and to choose the facial expression that best relates his/her current experience of discomfort to the previous one

Pain during injection using Sound, Eye, Motor (SEM) Scale

Time Frame: during local anesthesia administration

Sound, Eye, Motor (SEM) Scale was used as an objective mean to assess pain during local anesthesia administration. It comprises the following parameters: * Sound * Eye * Bodily movements The slightest changes in the sound, eye movement and bodily movement of the patient will be categorized as one of the following levels; comfortable, mild, moderate, and severe discomfort and hence given a grade of 1, 2, 3 or 4 respectively. The final SEM score will be calculated by adding the grades of the three parameters.

Study Sites (1)

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