Идёт набор NCT07400471
The Effects of Preemptive Multimodal Analgesic on Endodontic Pain Following Root Canal Therapy.
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: Pregabalin- Acetaminophen, Duloxetine- Acetaminophen.
- Кому может быть актуально
- Состояния в реестре: Post Endodontic Pain, Mechanical Detection Threshold, Mechanical Pain Threshold, Mechanical Pain Sensitivity. Базовые параметры: от 18 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
- Bangladesh
- 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
The Effects of Preemptive Multimodal Analgesic on Endodontic Pain.
Обзор
A clinical trial comparing preemptive multimodal analgesics with placebo in the management of immediate and chronic post-endodontic pain. The study utilizes statistical methods such as chi-squared, T-tests, and regression analysis, accounting for multiple outcomes with the Bonferroni adjustment. Duloxetine hydrochloride and pregabalin, both available in Bangladesh, are evaluated as experimental drugs, while placebos are used to assess psychological effects on pain. All participants receive standard interventional treatments, with acetaminophen provided as needed, and ethical considerations are addressed according to international guidelines.
Вмешательства
- Препарат Pregabalin- Acetaminophen
Preemptive Multi modal analgesic drug: Experimental group will be divided into 2 subgroups according to use of drug. A. Pregabalin-acetaminophen. B. Duloxetine-Acetaminophen Pregabalin-acetaminophen: Before a half-hour endodontic treatment, patients in this group will receive a single dosage of 50 mg pregabalin and 500 mg acetaminophen. If necessary, acetaminophen dosages of 500 mg will be administered three times a day. - Препарат Duloxetine- Acetaminophen
Duloxetine-Acetaminophen: Prior to a half-hour endodontic treatment, patients in this group will receive a single dosage of 500 mg of acetaminophen and 30 mg of Duloxetine. If necessary, acetaminophen dosages of 500 mg will be administered three times a day.
Первичные конечные точки
- Effects of Preemptive multimodal analgesia on post endodontic pain [Срок оценки: 6, 12, 24, 48, 72 hours]
Вторичные конечные точки (3)
- Mechanical Detection Threshold [Срок оценки: baseline, 72 hours]
- Mechanical Pain Threshold [Срок оценки: baseline, 72 hours]
- Mechanical Pain Sensitivity [Срок оценки: baseline, 72 hours]
Критерии участия
Критерии включения
- Patient's aged 18 years more.
- ASA physical status I-II.
- Patient with the complain of pain originated from teeth and surrounding structure.
- Preoperative pain severity is moderate to severe.
- Patient can be able to make communication about their pain.
- Patients give consent to attain this research.
- Patients have others concomitant chronic pain.
- Patients who will have non-surgical endodontic treatment.
- Patients who will have non-surgical endodontic retreatment.
- Patients who will have surgical endodontic treatment.
Критерии исключения
- Patient would not like to attain in research.
- Patients have any medical condition those are contra indication for study drug.
- ASA physical status III, IV, V.
- Patient already under treated any anti convulsent drug.
- Patient participant in other clinical trials.
- Lack of motivation or poor adharence to study protocols.
- Patient with Pregnancy
- Severe organ dysfunction
- Patient have Hepatitis B, and other cross infection disease like (HIV)
- Uncontrolled comorbidities that patient do not fit for endodontic treatment.
- Severe cognitive impaired patients.
- History of certain cancers or severe hematological issues.
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
- Тройное слепое
- Основная цель
- Лечение
Центры проведения
Bangladesh · 1 центр
- Professor. Dr. Md. Abu Saeed Ibn Harun — Chittagong
Публикации
- Anibal Diogenes, Michael A. Henry. Pain Pathways and Mechanisms of the Pulpodentin Complex. Chapter 8; Seltzer and Bender's Dental Pulp. 2nd edition. Quintessence Publishing Co Inc;2012.
- Jang YE, Kim Y, Kim BS. Influence of Preoperative Mechanical Allodynia on Predicting Postoperative Pain after Root Canal Treatment: A Prospective Clinical Study. J Endod. 2021 May;47(5):770-778.e1. doi: 10.1016/j.joen.2021.01.004. Epub 2021 Jan 29. PMID 33516824
- Alelyani AA, Azar PS, Khan AA, Chrepa V, Diogenes A. Quantitative Assessment of Mechanical Allodynia and Central Sensitization in Endodontic Patients. J Endod. 2020 Dec;46(12):1841-1848. doi: 10.1016/j.joen.2020.09.006. Epub 2020 Sep 15. PMID 32941893
- Wiech K, Ploner M, Tracey I. Neurocognitive aspects of pain perception. Trends Cogn Sci. 2008 Aug;12(8):306-13. doi: 10.1016/j.tics.2008.05.005. Epub 2008 Jul 5. PMID 18606561
- Md. Abu Saeed Ibn Harun et al. The dimension and severity of orofacial pain in patients with current and chronic odontogenic pain. M Dent J 2021; 41(3): 235-244.
- Woolf CJ. Windup and central sensitization are not equivalent. Pain. 1996 Aug;66(2-3):105-8. No abstract available. PMID 8880830
- Md. Abu Saeed Ibn Harun et al. Endogenous Pain modulation of Irreversible Pulpitis and Persistent Endodontic Pain. Chattagram International Dental College Journal 2019; 2(1):9-13.
- O'Keefe EM. Pain in endodontic therapy: preliminary study. J Endod. 1976 Oct;2(10):315-9. doi: 10.1016/S0099-2399(76)80047-7. No abstract available. PMID 1068208
Идентификаторы
NCT: NCT07400471 · ERC-BBS/2025/0015-44/2025