Analgesic Efficacy of Transcutaneous Electrical Nerve Stimulation and Dexketoprofen in Renal Colic
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: TENS, Dexketoprofen Trometamol.
- Кому может быть актуально
- Состояния в реестре: Renal Colic. 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
- Turkey (Türkiye)
- 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
Comparison of Analgesic Efficacy of Transcutaneous Electrical Nerve Stimulation and Dexketoprofen Trometamol in Patients Presenting to the Emergency Department With Renal Colic: A Randomized Controlled Trial
Обзор
The aim of this study was to compare the analgesic efficacy of transcutaneous electrical nerve stimulation (TENS) and dexketoprofen trometamol in patients presenting to the emergency department due to renal colic.
Подробное описание
Renal colic is a common presenting complaint to the emergency department and is an intensely painful condition. Parenteral opioids, non-steroidal anti-inflammatory drugs (NSAIDs) and paracetamol are commonly used to relieve the pain of renal colic. Dexketoprofen trometamol is a non-steroidal anti-inflammatory drug that is frequently used in the management of acute pain. Common and known side effects of nonsteroidal anti-inflammatory drugs include gastrointestinal system problems and allergic reactions. Transcutaneous electrical nerve stimulation is a non-invasive, non-pharmacological and low-risk treatment method. This study aimed to compare the analgesic efficacy of Transcutaneous electrical nerve stimulation and dexketoprofen trometamol in patients presenting to the emergency department with renal colic.
Study Design and Setting: A prospective, randomized, double-blind, single-center, clinical trial will be conducted in emergency department of a tertiary care university hospital.
Statistical Analysis:
Categorical variables will be presented as numbers and percentages. The Kolmogorov-Smirnov test will be used to evaluate the normality of the distribution of continuous variables. Continuous variables with a non-normal distribution will be expressed as the median and interquartile range (IQR), and those with a normal distribution will be expressed as the mean and standard deviation (SD). The Mann-Whitney U test will be used to analyse non-normally distributed variables to evaluate the differences in visual analog scale scores between the two groups; the Student's t-test will be used for normally distributed variables.
The sample size was calculated using the G\*Power 3.1.9.2 programme. According to the data obtained from the study of renal colic therapy with TENS, a difference of 18.4 mm in visual analogue scale score between the two groups with a standard deviation of 6 mm was assumed. It was calculated that 64 patients were required for each group with a two-sided critical value of α = 0.05, 95% power and an effect size of 0.5.
Вмешательства
- Устройство TENS
Transcutaneous electrical nerve stimulation (TENS) treatment will be activated + NS IV Infusion 100 ml - Препарат Dexketoprofen Trometamol
50 mg dexketoprofen trometamol in 100 ml normal saline solution + Transcutaneous electrical nerve stimulation treatment will not be activated.
Первичные конечные точки
- Change of the intensity of pain [Срок оценки: 15 minutes and 30 minutes after the administration of the study interventions]
Вторичные конечные точки (2)
- Adverse events [Срок оценки: 30 minutes after]
- need to rescue medication [Срок оценки: 30 minutes after]
Критерии участия
Критерии включения
\- Aged 18 years or over with a definite diagnosis of renal colic
Критерии исключения
- Patients who refuse to participate in the study
- Pregnant women
- Breastfeeding women
- Haemodynamically unstable
- Evidence of peritoneal inflammation
- Patients who were taking analgesics at the time of initial presentation
- Unconsciousness or inability to communicate
- Contraindications to applying TENS or using the drug in the study.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
Turkey (Türkiye) · 1 центр
- Adiyaman University Medical Faculty — Adıyaman
Публикации
- Gulacti U, Algin A, Turgut K, Yavuz E, Aydin I, Buyukaslan H, Lok U, Arslan E, Gonel A. Transcutaneous Electrical Nerve Stimulation (TENS) for the Treatment of Renal Colic in the ED: A Randomized, Double-Blind, Placebo-Controlled Trial. Am J Emerg Med. 2022 Jun;56:127-132. doi: 10.1016/j.ajem.2022.02.044. Epub 2022 Mar 29. PMID 35397352
- Al B, Sunar MM, Zengin S, Sabak M, Bogan M, Can B, Kul S, Murat Oktay M, Eren SH. Comparison of IV dexketoprofen trometamol, fentanyl, and paracetamol in the treatment of renal colic in the ED: A randomized controlled trial. Am J Emerg Med. 2018 Apr;36(4):571-576. doi: 10.1016/j.ajem.2017.09.019. Epub 2017 Sep 14. PMID 29029797
- Hanna M, Moon JY. A review of dexketoprofen trometamol in acute pain. Curr Med Res Opin. 2019 Feb;35(2):189-202. doi: 10.1080/03007995.2018.1457016. Epub 2018 Apr 24. PMID 29569951
Идентификаторы
NCT: NCT07176572 · RK-TENSE-2025-AEAH