Buffered Versus Conventional Local Anesthesia for Pain and Anxiety Reduction in School-Aged Children With Pulpitis

Официальное название

Efficacy of Buffered Versus Conventional Local Anesthesia for Reducing Pain and Anxiety During Dental Treatment in School-Aged Children Diagnosed With Pulpitis: A Randomized Controlled Clinical Trial

Обзор

The objective of this clinical trial is to evaluate whether buffered local anesthesia is more effective than conventional local anesthesia in reducing pain responses in school-aged children requiring dental treatment for pulpitis. The study will also assess differences in physiological and self-reported indicators of pain and anxiety, as well as anesthetic onset and duration. The main questions it aims to answer are: Does buffered local anesthesia reduce behavioral pain scores measured by the FLACC scale compared to conventional local anesthesia? Does buffered local anesthesia improve physiological and psychometric indicators of pain and anxiety during dental procedures? Methodology: The researchers will compare buffered local anesthesia with conventional local anesthesia during routine dental treatment procedures such as pulpotomy or pulpectomy in primary molars. Participants will: Receive either buffered or conventional local anesthesia during dental treatment Undergo pulpotomy or pulpectomy depending on clinical diagnosis Be monitored for pain and anxiety using FLACC scale, heart rate, skin conductance, and Wong-Baker Faces Pain Scale at different stages of treatment Have the onset and duration of anesthesia recorded during and after the procedure Be followed until recovery of soft tissue sensation after treatment

Вмешательства

• Препарат Buffered Lidocaine with Epinephrine
  Local anesthetic solution buffered with sodium bicarbonate prior to administration in order to increase pH and potentially improve onset and patient comfort during dental procedures.
• Препарат idocaine with Epinephrine (Conventional)
  Standard commercially available local anesthetic solution used in routine dental practice without pH modification

Первичные конечные точки

• FLACC PAIN SCORE [Срок оценки: Baseline (before local anesthetic administration), during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)]

Вторичные конечные точки (5)

• Physiological indicators (Heart Rate) [Срок оценки: Baseline, during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)]
• Physiological indicators (Skin Conductance) [Срок оценки: Baseline, during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)]
• Wong-Baker Faces Pain Rating Scale Score [Срок оценки: Baseline (before local anesthetic administration, during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)]
• Onset of local anesthesia [Срок оценки: From completion of anesthetic injection until confirmation of pulpal anesthesia during the treatment visit.]
• Duration of soft tissue anesthesia [Срок оценки: From confirmation of soft tissue anesthesia immediately after injection until complete recovery of sensation, assessed up to 6 hours after treatment.]

Критерии участия

Критерии включения

• Children aged 6 to 12 years
• Diagnosis of irreversible pulpitis due to dental caries in primary maxillary molars
• American Society of Anesthesiologists (ASA) Physical Status Classification I
• Cooperative or definitely cooperative behavior according to Frankl Behavioral Scale (Frankl III or IV)
• Written informed consent provided by parent or legal guardian, and child assent when applicable
• No use of analgesic or anti-inflammatory medication within 24 hours prior to the procedure

Критерии исключения

• Known allergy to any component of local anesthetic solution
• History of negative or traumatic dental experiences within the previous 12 months that may interfere with behavioral assessment
• Radiographic evidence of periapical pathology associated with the affected tooth
• Presence of localized abscess or acute spreading infection at the injection site

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Мексика · 1 центр

• Universidad Autónoma de San Luis Potosí — San Luis Potosí City

Публикации

• Aulestia-Viera PV, Braga MM, Borsatti MA. The effect of adjusting the pH of local anaesthetics in dentistry: a systematic review and meta-analysis. Int Endod J. 2018 Aug;51(8):862-876. doi: 10.1111/iej.12899. Epub 2018 Feb 21. PMID 29377171
• Kurien RS, Goswami M, Singh S. Comparative evaluation of anesthetic efficacy of warm, buffered and conventional 2% lignocaine for the success of inferior alveolar nerve block (IANB) in mandibular primary molars: A randomized controlled clinical trial. J Dent Res Dent Clin Dent Prospects. 2018 Spring;12(2):102-109. doi: 10.15171/joddd.2018.016. Epub 2018 Jun 20. PMID 30087760

Идентификаторы

NCT: NCT07638254 · CEI-FE-041-025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗