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Clinical Trials/NCT05857033
NCT05857033Active, not recruitingNot Applicable

Effectiveness of Cold Vibratory Stimuli on Pain Perception Governing Infiltration Anesthesia in the Maxillary Arch in Children: a Randomized Controlled Clinical Trial

Alexandria University1 site in 1 country48 target enrollmentStarted: January 5, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
48
Locations
1
Primary Endpoint
Change in pain scores
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Local anesthesia injections are sometimes painful, resulting in antagonistic cooperation, fear, and anxiety in children. This study aims to investigate the effectiveness of vibratory and cold stimulation before the injection to reduce pain. Purpose of the study: Evaluate the effectiveness of Buzzy® in pain reduction during local anesthesia administration compared to the traditional topical anesthetic gel in pediatric patients.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Participant)

Eligibility Criteria

Ages
5 Years to 8 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients who are in need of extraction of maxillary posterior teeth.
  • •Children free of any systemic disease or special health care needs (ASA I).
  • •Children with no learning disabilities.
  • •Positive or definitely positive behavior during preoperative assessments according to the Frankl Scale.
  • •Patients whose parents will give consent to participate.

Exclusion Criteria

  • •Having active sites of pathosis in the area of injection that could affect the anesthetic assessment.
  • •Signs of reversible pulpitis.
  • •Restorable tooth.
  • •Patients allergic to local anesthesia or having a family history of allergy to local anesthesia.
  • •Patients with acute oral or facial infection (swelling and/or cellulites )

Outcomes

Primary Outcomes

Change in pain scores

Time Frame: Baseline and up to 1 hour

Visual Analogue Scale is used and it ranges from 0 to 10. the ''0'' point indicates ''no pain'' and ''10'' point indicates the worst possible pain.

Change in child's behavior

Time Frame: During the procedure

Sound, eye,motor (SEM) scale is used. it assess child's pain perception by observing discomfot levels on SEM during injections. Total scores for SEM range from 0 to 9 based on 0-3 score for each parameter. Score 0: Comfort Score 1: Mild disocomfort Score 2: Moderate discomfort Score 3: Severe discomfort

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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