drugset / Trial / NCT07316660

Palmitoylethanolamide vs Ibuprofen for Pain After ESWL

NCT07316660

Not yet recruiting 120 enrolled Benha University
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2026-01-01
Primary completion
2026-06-01
Completion
2026-07-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ibuprofen Small molecule 400 mg Oral
Subject Palmidrol Small molecule 600 mg Oral

Indications

No indication recorded.