Electronic vs. Conventional Syringes: Impact on Pediatric Pain and Anxiety

Condition(s) studied

Investigational drug(s) / intervention(s)

Electronic anesthesia: The child will receive electronic anesthesia to the right side of the upper jaw; the pain and anxiety level will be assessed.

Conventional anesthesia: The child will receive conventional anesthesia to the maxillary left side

Study 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.

Eligibility

Primary outcome measure(s)

• Pain Perception — 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.

Trial sites (1)

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