Набор скоро начнётся NCT07316660

Palmitoylethanolamide vs Ibuprofen for Pain After ESWL

Без фазы С лечением Pain After Extracorporeal Shock Wave Lithotripsy Palmitoylethanolamide

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: Palmitoylethanolamide (PEA), Ibuprofen (Brufen®).
Кому может быть актуально: Состояния в реестре: Pain After Extracorporeal Shock Wave Lithotripsy, Palmitoylethanolamide. Базовые параметры: 18 лет — 65 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

Palmitoylethanolamide Versus Ibuprofen for Acute Postoperative Pain After Extracorporeal Shock Wave Lithotripsy: A Randomized Trial

Обзор

Pain after extracorporeal shock wave lithotripsy (ESWL), a non-surgical procedure used to treat kidney stones, is common and is usually treated with non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen. However, NSAIDs may cause side effects in some patients, including stomach irritation and kidney problems. Palmitoylethanolamide (PEA) is a naturally occurring substance in the body with anti-inflammatory and pain-relieving properties and has been shown to be safe in previous studies. This study aims to compare the effectiveness of PEA with ibuprofen for controlling acute postoperative pain after ESWL. Participants undergoing ESWL will be randomly assigned to receive either oral PEA or oral ibuprofen. Pain intensity will be measured using a visual analogue scale during the first 24 hours after the procedure. The use of rescue pain medication and any side effects will also be recorded. The results of this study may help determine whether PEA can be an effective alternative to ibuprofen for the management of acute pain after ESWL.

Вмешательства

Препарат Palmitoylethanolamide (PEA)
Palmitoylethanolamide (PEA) will be administered orally at a dose of 600 mg approximately 60 minutes before ESWL, followed by 600 mg every 8 hours for the first 24 hours after the procedure (total of three doses). PEA will be provided as a micronized or ultramicronized formulation. Participants will be allowed to receive rescue analgesia according to the study protocol if pain is not adequately controlled.
Препарат Ibuprofen (Brufen®)
Ibuprofen will be administered orally at a dose of 400 mg approximately 60 minutes before ESWL, followed by 400 mg every 8 hours for the first 24 hours after the procedure (total of three doses), in accordance with standard clinical practice. Participants will be allowed to receive rescue analgesia according to the study protocol if pain is not adequately controlled.

Первичные конечные точки

Postoperative pain intensity measured by Visual Analogue Scale (VAS) [Срок оценки: 2 hours after ESWL]

Вторичные конечные точки (5)

Pain intensity over the first 24 hours after ESWL [Срок оценки: From recovery room arrival up to 24 hours after ESWL]
Time to first rescue analgesia [Срок оценки: Up to 24 hours after ESWL]
Total rescue analgesic consumption within 24 hours [Срок оценки: Up to 24 hours after ESWL]
Proportion of patients achieving clinically meaningful pain relief [Срок оценки: Within 24 hours after ESWL]
Incidence of adverse events [Срок оценки: From first dose of study medication up to 7 days after ESWL]

Критерии участия

Критерии включения

Age 18-65 years
ASA I or II
Undergoing elective ESWL for renal or upper ureteric calculi
Expected discharge same day or within 24 hours (outpatient ESWL).
Able to provide informed consent and comply with study procedures (including diary/VAS recordings).
Not currently taking chronic NSAIDs, opioids, or PEA supplements for ≥7 days prior to ESWL.