Palmitoylethanolamide vs Ibuprofen for Pain After ESWL

Benha University

Status: Not yet enrolling

Conditions: Palmitoylethanolamide; Pain After Extracorporeal Shock Wave Lithotripsy

Treatments: Drug: Palmitoylethanolamide (PEA); Drug: Ibuprofen (Brufen®)

Study type: Interventional

Funder types: Other

Identifiers

NCT07316660

RC.19.10.2025

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

120 participants in 2 patient groups

Palmitoylethanolamide Group

Experimental group

Description:

Participants assigned to this arm will receive oral palmitoylethanolamide for management of acute postoperative pain following extracorporeal shock wave lithotripsy (ESWL). Rescue analgesia will be available if required.

Treatment:

Drug: Palmitoylethanolamide (PEA)

Ibuprofen Group

Active Comparator group

Description:

Participants assigned to this arm will receive oral ibuprofen for management of acute postoperative pain following extracorporeal shock wave lithotripsy (ESWL). Rescue analgesia will be available if required.

Treatment:

Drug: Ibuprofen (Brufen®)