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

Not Applicable

Completed

• Conditions: Local Anesthesia; Dental Anesthesia
• Interventions: Other: Local anesthesia solution pre-warmed to 37°C; Other: Local anesthesia solution at room temperature; Other: Local anesthesia solution pre-warmed to 40°C; Other: Inferior alveolar nerve block technique; Other: Maxillary infiltration technique

• Registration Number: NCT06519838
• Lead Sponsor: Andrew Emad

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Primary Completion: 2024-06-10
• Study Completion: 2024-06-10
• Status Verified: 2024-07
• Study First Submitted: 2024-07-14
• Study First Submitted QC: 2024-07-20
• Last Update Submitted: 2024-07-20
• Study First Posted: 2024-07-25
• Last Update Posted: 2024-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inferior alveolar nerve block at room temperature	Inferior alveolar nerve block technique	-
Inferior alveolar nerve block pre-warmed to 37°C	Local anesthesia solution pre-warmed to 37°C	-
Inferior alveolar nerve block pre-warmed to 37°C	Inferior alveolar nerve block technique	-
Maxillary infiltration pre-warmed to 37°C	Local anesthesia solution pre-warmed to 37°C	-
Maxillary infiltration pre-warmed to 40°C	Maxillary infiltration technique	-
Inferior alveolar nerve block pre-warmed to 40°C	Inferior alveolar nerve block technique	-
Inferior alveolar nerve block at room temperature	Local anesthesia solution at room temperature	-
Maxillary infiltration at room temperature	Local anesthesia solution at room temperature	-
Maxillary infiltration at room temperature	Maxillary infiltration technique	-
Maxillary infiltration pre-warmed to 40°C	Local anesthesia solution pre-warmed to 40°C	-
Inferior alveolar nerve block pre-warmed to 40°C	Local anesthesia solution pre-warmed to 40°C	-
Maxillary infiltration pre-warmed to 37°C	Maxillary infiltration technique	-

Primary Outcome Measures

Name	Time	Method
Heart rate (HR) monitoring	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	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	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.

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt