Comparing pain relief methods for dental injections in children
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.
This study is testing whether a spray or a gel can help reduce pain for kids aged 7 to 10 during dental injections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 7 Years to 10 Years |
| Sex | All |
| Sponsor | Mohammed Bin Rashid University of Medicine and Health Sciences Academic / other |
| Locations | 1 site (Multiple Locations) |
| Trial ID | NCT06011005 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Ethyl Chloride topical spray versus Benzocaine gel in reducing pain perception during dental injections in children aged 7 to 10 years. The study involves a single-blinded randomized controlled design where participants will receive either the Ethyl Chloride spray or Benzocaine gel before undergoing a maxillary buccal infiltration. Pain perception will be assessed using various scales, including the Visual Analog Scale and Facial Pain Scale, while monitoring heart rate as an additional measure of discomfort. The trial is conducted at the Pediatric Dentistry Department of Dubai Dental Hospital.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy children aged 7 to 10 years who require maxillary buccal infiltration and have no prior history of local anesthesia.
Not a fit: Patients with a history of medically compromised conditions, allergies to local anesthesia, or those requiring treatment under conscious sedation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management techniques for children undergoing dental procedures.
How similar studies have performed: Previous studies have explored various topical anesthetics, but the specific comparison of Ethyl Chloride and Benzocaine in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Multiple Locations
- Mohammed Bin Rashid University Of Medicine and Health Sciences — Multiple Locations, United Arab Emirates (Recruiting)
Study contacts
- Principal investigator: Nagah Abdelrahman — Mohammed Bin Rashid University of Medicine and Health Sciences
- Study coordinator: Nagah Abdelrahman
- Email: Nagah.abdelrahman@residents.mbru.ac.ae
- Phone: 971551225599
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.