Идёт набор NCT07045116

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

Без фазы С лечением Dental Anxiety Pain Management

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Electronic anesthesia, Conventional anesthesia.
Кому может быть актуально: Состояния в реестре: Dental Anxiety, Pain Management. Базовые параметры: 6 лет — 8 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Египет
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effectiveness of Electronic Anesthesia Delivery Syringe Versus Conventional Syringe on Pain and Anxiety Perception During Local Anesthetic Injection in Children Randomized Clinical Trial

Обзор

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.

Подробное описание

1. 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.

Outcomes:

Primary: Pain measured by Visual Analogue Scale (VAS).

Secondary: Heart rate, oxygen saturation, and salivary amylase (stress biomarker) using ELISA. 3. Background Local anesthesia is a primary source of fear in children due to needle insertion, pressure, and speed of delivery.

Minimizing pain and anxiety is critical for long-term positive dental attitudes.

Electronic anesthesia devices may reduce these discomforts through:

Controlled delivery rate.

Reduced injection pressure.

Numbing tissue ahead of the needle. 4. Research Question (PICOTS Framework) Population: 40 children (6-8 years old).

Intervention: Electronic anesthesia.

Comparator: Conventional anesthesia.

Outcome: Pain (VAS), heart rate, oxygen saturation, salivary amylase.

Time: Two visits.

Setting: Ain Shams University Pediatric Dentistry outpatient clinic (Jan 2024-Jan 2025). 5. Aim and Objectives Aim: To assess pain and anxiety levels during local anesthesia using electronic vs. conventional syringes.

Primary Outcome:

Pain via VAS before and after anesthesia.

Secondary Outcomes:

Heart rate and oxygen saturation using pulse oximetry.

Salivary amylase levels via ELISA test. 6. Hypothesis Null Hypothesis (H0): No difference between electronic and conventional anesthesia in reducing pain and anxiety. 7. Ethical Considerations Risks: Pain, discomfort, self-injury post-procedure, potential allergic reactions.

Risk Minimization:

Proper selection and dosage of anesthetic agents.

Use of topical anesthetic pre-injection.

Postoperative instructions to avoid tissue trauma.

Privacy \& Confidentiality: Anonymized data using patient codes.

Informed Consent: Written consent and assent obtained.

Adverse Events: Monitored and reported with defined procedures.

Sample Disposal: Discarded as biohazardous waste after study completion. 8. Study Design Type: Randomized Controlled Trial (RCT).

Design: Split-mouth, double-blinded.

Blinding:

Patients blinded with sunglasses.

Statistician and assessors blinded to allocation.

Randomization Tool: Sealed Envelope computer-generated randomization.

Allocation Concealment: Handled by a third party. 9. Materials and Methods Study Population

Inclusion Criteria:

6-8 years old.

Medically free (ASA I).

Вмешательства

Устройство Electronic anesthesia
The child will receive electronic anesthesia to the right side of the upper jaw; the pain and anxiety level will be assessed.
Устройство Conventional anesthesia
The child will receive conventional anesthesia to the maxillary left side

Первичные конечные точки

Pain Perception [Срок оценки: Timing: Immediately after the administration of local anesthesia (both electronic and conventional)]

Вторичные конечные точки (3)

Heart Rate (HR) [Срок оценки: Immediately before and after the administration of local anesthesia (both electronic and conventional)]
Oxygen Saturation [Срок оценки: Immediately before and after both the Electronic and Conventional anesthesia]
Salivary amylase level [Срок оценки: 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)]

Критерии участия

Критерии включения

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.