Efficacy of Ethyl Chloride Topical Anesthesia Application on the Pain Perception During Intra-oral Injections in Children in Comparison to Benzocaine Gel.

Study Overview
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Brief Summary
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The goal of this single-blinded randomized controlled trial is to compare pain perception during buccal infiltration using indirect EC spray and topical anesthesia and BC 20% topical gel, among seven to 10-year-old school children who attended Pediatric Dentistry Department at Dubai Dental Hospital (DDH), Mohammed Bin Rashid University (MBRU) in Dubai, the United Arab Emirates (UAE). The main question[s] it aims to answer are: • How effective is the indirect application of EC topical spray anesthesia on pain perception during intraoral buccal injection in children in comparsion to BC 20%? Researchers will compare efficacy of 20% Benzocaine (BC) gel and indirect application of Ethyl Chloride (EC) spray to see if reducing pain perception during local anesthesia infiltration.

Detailed Description
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Pre-local analgesia topical Benzocaine gel or Ethyl Chloride technique will be selected randomly and applied per the protocol. A single calibrated operator (A.A) using randomly selected sealed envelopes that have been previously divided equally according to sample size arms. The selected envelope is then opened by the operator, who applies either the EC or BC topical anesthesia technique based on the chosen envelop. Followed by maxillary local analgesia buccal infiltration for a single tooth by a calibrated operator (A.A). The child is then observed and assessed by the blinded primary investigator (N.A) (to the topical anesthesia technique) for pain perception during local anesthesia infiltration based on the Sound, Eye, Motor index used in this study. The child is then asked to rate the Visual Analog Scale and Facial Pain Scale. Heart rate of the patient will be recorded as per below protocol.

Official Title
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Efficacy of Ethyl Chloride Topical Anesthesia Application on the Pain Perception During Intra-oral Injections in Children in Comparison to Benzocaine Gel- a Single-blinded Randomized Controlled Trial.

Conditions
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Dental Caries in Children, Anesthesia, Local, Injection Site Discomfort

Intervention / Treatment
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* Other: Ethyl Chloride spray (group A)
* Other: Benzocaine gel 20% (group B)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy children (ASA I) aged between 7 - 10 years old. Needing any maxillary buccal infiltration (anterior, middle, posterior) Had no prior history of local anesthesia. Frankl behavior III or IV Not taking any painkillers, or other drugs that would influence with their pain perception. Exclusion Criteria: History of a medically compromised condition and intellectual disability. § Any allergy to local anesthesia. Active pathology at the site of injection. Prior history of intra-oral injection. Frankl behavior I or II. Children/parents not willing to participate in the study. § Needle phobia. Patients require treatment under conscious sedation.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: (Group A) Ethyl Chloride (EC)<br>Topical application for 30 sec. | Other: Ethyl Chloride spray (group A)<br>* Cold test spray<br>|
| Active Comparator: (Group B) Benzocaine gel 20% (BC)<br>BC 20% Topical gel application for 30 sec and left for 1 minute. | Other: Benzocaine gel 20% (group B)<br>* Topical analgesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Each participant's heart rate will be recorded immediately before and after the injection using an FDA-approved pulse oximeter. | 5-10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sound, Eye, Motor (SEM) Index | During the insertion of the needle, the operator will evaluate the patient's behavior for pain perception using sound, eye, motor (SEM) scale and visual analog scale (VAS). | 5-10 minutes | 
| Visual Analog Scale (VAS) | The VAS scale is a 100-mm long horizontal line labeled no pain: at one end and worst pain possible at the other. After each procedure (EC or BC), the participants are asked to evaluate the degree of pain (primary outcome) they experienced using the Facial Pain Scale below. | 5-10 minutes | 
| Face Pain Scale | These faces show how much something can hurt. This face (point to leftmost face] shows no pain. The faces show more and more pain [point to each from left to the right] up to this one [point to rightmost face] - it shows very much pain. Point to the face that shows how much the child is hurt. Score the chosen face 0, 2, 4, 6, 8, or 10, counting left to right, so ''0' = 'no pain' and ''10' = 'very much pain. Do not use words like happy' and ''sad'. This scale is intended to measure how children feel inside, not how their face looks. Brief word instructions: Point to each face using the words to describe the pain intensity. Ask the children to choose a face that best describes their pain and record the appropriate number. | 5-10 minutes |