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

Mohammed Bin Rashid University of Medicine and Health Sciences

Status

Enrolling

Conditions

Anesthesia, Local

Dental Caries in Children

Injection Site Discomfort

Treatments

Other: Benzocaine gel 20% (group B)

Other: Ethyl Chloride spray (group A)

Study type

Interventional

Funder types

Other

Identifiers

NCT06011005

MBRU IRB-2022-174

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 estimated patients

Sex

All

Ages

7 to 10 years old

Volunteers

Accepts Healthy Volunteers

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.