Effectiveness of Electronic Anesthesia Delivery Syringe Versus Conventional Syringe on Pain and Anxiety Perception During Local Anesthetic Injection in Children Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Pain Perception
Study Overview
Brief Summary
Study Overview Purpose: To compare pain and anxiety levels in children aged 6-8 during local anesthesia administration using electronic vs. conventional syringes.
Design: Split-mouth randomized controlled trial (RCT) involving 40 children receiving both types of anesthesia during pulp therapy of bilateral maxillary primary molars.
Objectives Primary Outcome: Pain level measured via Visual Analogue Scale (VAS).
Secondary Outcomes:
Physiological markers: heart rate and oxygen saturation via pulse oximetry.
Salivary amylase levels (anxiety biomarker) assessed using ELISA.
Methodology Children are randomly assigned to receive electronic anesthesia on one side and conventional on the other in two separate visits.
Saliva samples are collected before and after each injection.
Double-blind setup: children blinded using sunglasses; statistician also blinded.
Same operator administers all injections for consistency.
Ethical Considerations Written informed consent and assent obtained.
Risks (e.g., systemic toxicity, allergic reactions) minimized via dosage limits and patient monitoring.
Privacy and data security measures in place.
Statistical Analysis Data analyzed using SPSS; significance set at p ≤ 0.05.
Sample size calculated for adequate power (n = 33 minimum; 40 enrolled).
Funding Self-funded.
Clinical Relevance Electronic anesthesia may offer a less painful and anxiety-inducing alternative for pediatric dental patients, potentially improving children's long-term attitude toward dental care.
Detailed Description
- Title and Context Title: Effectiveness of Electronic Anesthesia Delivery Syringe Versus Conventional Syringe on Pain and Anxiety Perception During Local Anesthetic Injection in Children.
Submitted by: Randa Omer Ahmed Bashir, for partial fulfillment of a master's degree in Pediatric Dentistry at Ain Shams University.
Supervisors: Assoc. Prof. Dr. Reham Khaled Elghazawy and Dr. Nour Abdelmonem Wahba. 2. Abstract Problem Statement: Local anesthesia causes pain and anxiety, especially in children.
Objective: To compare electronic vs. conventional anesthesia during pulp therapy in 6-8-year-old children.
Design: Split-mouth RCT involving 40 children.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 8 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •6-8-year-old children.
- •Medically free (ASA class I).
- •Children attending their first dental visit.
- •The patient should have at least one vital primary molar with deep carious lesion on each side.
Exclusion Criteria
- •Patient has any allergy to local anesthesia.
- •Patients take any medications that affect the salivary flow.
- •Patient taken corticosteroid.
- •Children whose parents or legal guardians refuse to sign the informed consent.
Arms & Interventions
Maxillary right primary molar
Maxillary right primary molar will receive electronic anesthesia
Intervention: Electronic anesthesia (Device)
Maxillary left primary molar
Maxillary left primary molar will receive conventional anesthesia
Intervention: Conventional anesthesia (Device)
Outcomes
Primary Outcomes
Pain Perception
Time Frame: Timing: Immediately after the administration of local anesthesia (both electronic and conventional)
Tool: Visual Analogue Scale (VAS) Scale: 0 (no pain) to 10 (worst possible pain) Purpose: To quantitatively assess the child's subjective pain level post-injection.
Secondary Outcomes
- Salivary amylase level(Before any injection (baseline) - After conventional anesthesia (The saliva samples must be collected up to 30 minutes after the injection) - After electronic anesthesia (The saliva samples must be collected up to 30 minutes after the injection))
- Salivary amylase level(Before any injection (baseline) - After conventional anesthesia (The saliva samples must be collected up to 30 minutes after the injection) - After electronic anesthesia (The saliva samples must be collected up to 30 minutes after the injection))
- Heart Rate (HR)(Immediately before and after the administration of local anesthesia (both electronic and conventional))
- Oxygen Saturation(Immediately before and after both the Electronic and Conventional anesthesia)
Investigators
Randa Omer Ahmed Bashir
Master's degree candidate at Pediatric department, Ain Shams University
Ain Shams University