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NCT Number: NCT06519838

Effect of Pre-Warming of Local Anesthesia in Reducing Pain Perception During Injection in Children

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

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Key information

Conditions

Local Anesthesia Dental Anesthesia

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy patients with ASA 1 or 2 Classification.
  • Patients with Frankl Behavior Classification 3-4.
  • 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.

Treatment and study plan

Local anesthesia solution at room temperature

Other

The local anesthesia cartridge is used at room temperature (average of 21 °C)

Local anesthesia solution pre-warmed to 37°C

Other

About 150 ml of water at 21°C is added to the heating compartment of the heating device. The Local anesthesia cartridge is placed at the bottom of the heating compartment. The device is plugged in and the control gauge is set at the "Express milk warming setting for contents up to 180ml/6oz" mark. The contents would reach 37°C at 120 seconds.

Local anesthesia solution pre-warmed to 40°C

Other

About 150 ml of water at 21°C is added to the heating compartment of the heating device. The Local anesthesia cartridge is placed at the bottom of the heating compartment. The device is plugged in and the control gauge is set at the "Express milk warming setting for contents up to 180ml/6oz" mark. The contents would reach 40°C at 130 seconds.

Maxillary infiltration technique

Other

A 30 gauge short needle is oriented so that the bevel is facing the bone. The syringe is held parallel to the long axis of the tooth and the needle is inserted into the height of the mucobuccal fold over the offending tooth. The needle is advanced to a depth of 1 millimeter into the tissues. Aspiration is done, and once it is negative then 0.6 ml (nearly one third of the cartridge) of the anesthetic solution is injected slowly without permitting the tissues to balloon.

Inferior alveolar nerve block technique

Other

While the mouth is opened as wide as possible, the index finger palpates the external oblique ridge reaching the Coronoid notch. A 27-gauge long dental needle will be used for injection. The needle will be directed between the two primary molars on the opposing side of the arch, penetrating the tissues at the point halfway between coronoid notch and the pterygomandibular raphe at the occlusal plane level or slightly lower.The needle is withdrawn 2mm to aspirate. Once negative aspiration is checked, the remainder of the solution is deposited slowly. Approximately 1.0 mL of LA will be delivered near the inferior alveolar nerve. The average depth of insertion is about 15mm, which is nearly two-thirds the needle length.

Primary outcomes

  1. 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.

  2. 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.

  3. 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:

    • Satisfaction
    • Indifference
    • 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

Sponsors and collaborators

Lead sponsor

Andrew Emad

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 25, 2024
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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