Palmitoylethanolamide vs Ibuprofen for Pain After ESWL

NCT ID: NCT07316660

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-07-01

Brief 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.

Conditions

Pain After Extracorporeal Shock Wave Lithotripsy; Palmitoylethanolamide

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Palmitoylethanolamide Group

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.

Group Type: EXPERIMENTAL

Palmitoylethanolamide (PEA)

Intervention Type: DRUG

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.

Ibuprofen Group

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.

Group Type: ACTIVE_COMPARATOR

Ibuprofen (Brufen®)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Samar Rafik Mohamed Amin

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Benha University Hospital

Banhā, Qalyubia Governorate, Egypt

Countries

Egypt

Central Contacts

Samar R Amin, M.D.

Role: CONTACT

samar.rafik@gmail.com

+201287793991

Facility Contacts

Samar Amin, MD

Role: primary

samar.rafik@gmail.com

+201287793991

Other Identifiers

RC.19.10.2025

Identifier Type: -

Identifier Source: org_study_id