An interventional study of Local anesthesia solution at room temperature and Local anesthesia solution pre-warmed to 37°C in Local Anesthesia and Dental Anesthesia, sponsored by Andrew Emad. Completed at 1 site in Egypt. Open to participants aged 5 Years to 7 Years. Per ClinicalTrials.gov, last updated 2024-07-25.
Sponsored by Andrew Emad · Not applicable, Interventional, and Treatment
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
This is the only study on the registry with Andrew Emad as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Local anesthesia solution at room temperature · Other: Maxillary infiltration technique
Other: Local anesthesia solution at room temperature · Other: Inferior alveolar nerve block technique
Other: Local anesthesia solution pre-warmed to 37°C · Other: Maxillary infiltration technique
Other: Local anesthesia solution pre-warmed to 37°C · Other: Inferior alveolar nerve block technique
Other: Local anesthesia solution pre-warmed to 40°C · Other: Maxillary infiltration technique
Other: Local anesthesia solution pre-warmed to 40°C · Other: Inferior alveolar nerve block technique
The local anesthesia cartridge is used at room temperature (average of 21 °C)
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.
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.
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.
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.
Heart rate (HR) monitoring
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.
Time frame: during local anesthesia administration
Pain during injection using Sound, Eye, Motor (SEM) Scale
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.
Time frame: during local anesthesia administration
Pain during injection using Face scale
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
Time frame: during local anesthesia administration
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.