Palmitoylethanolamide vs Ibuprofen for Pain After ESWL (NCT07316660) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Palmitoylethanolamide vs Ibuprofen for Pain After ESWL
Egypt120 participantsStarted 2026-01-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Chronic pain or daily analgesic use.
* Known allergy or contraindication to PEA, ibuprofen.
* Active peptic ulcer disease, known bleeding disorder, anticoagulant therapy
* Pregnancy or lactation.
* Use of steroids or other pain-modulating drugs.
* Severe renal impairment (eGFR \<30 mL/min/1.73 m²).
* Hepatic failure or significant liver enzyme elevation (AST/ALT \>3× ULN).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative pain intensity measured by Visual Analogue Scale (VAS)