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

August 22, 2023 updated by: Nagah ABdelrahman, Mohammed Bin Rashid University of Medicine and Health Sciences

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Arab Emirates
      • Multiple Locations, United Arab Emirates
        • Recruiting
        • Mohammed Bin Rashid University of Medicine and Health Sciences
        • Contact:
        • Principal Investigator:
          • Nagah Abdelrahman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: 5-10 minutes
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
Time Frame: 5-10 minutes
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)
Time Frame: 5-10 minutes
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
Time Frame: 5-10 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohammed Bin Rashid University of Medicine and Health Sciences

Investigators

  • Principal Investigator: Nagah Abdelrahman, Mohammed Bin Rashid University of Medicine and Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

October 24, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

July 5, 2023

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 25, 2023

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBRU IRB-2022-174

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Study Protocol
    Information identifier: MBRU IRB-2022-174

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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