Palmitoylethanolamide vs Ibuprofen for Pain After ESWL

NCT07316660 | Not Yet Recruiting

• 1 other identifier: RC.19.10.2025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity measured by Visual Analogue Scale (VAS)

  Pain intensity will be assessed using a 10-cm visual analogue scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. The primary comparison will be the VAS score measured 2 hours after extracorporeal shock wave lithotripsy (ESWL) between the palmitoylethanolamide and ibuprofen groups.

  2 hours after ESWL

Secondary Outcomes (5)

• Pain intensity over the first 24 hours after ESWL

  From recovery room arrival up to 24 hours after ESWL

• Time to first rescue analgesia

  Up to 24 hours after ESWL

• Total rescue analgesic consumption within 24 hours

  Up to 24 hours after ESWL

• Proportion of patients achieving clinically meaningful pain relief

  Within 24 hours after ESWL

• Incidence of adverse events

  From first dose of study medication up to 7 days after ESWL

Study Arms (2)

Palmitoylethanolamide Group

EXPERIMENTAL

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.

Drug: Palmitoylethanolamide (PEA)

Ibuprofen Group

ACTIVE COMPARATOR

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.

Drug: Ibuprofen (Brufen®)

Interventions

Palmitoylethanolamide (PEA) 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.

Palmitoylethanolamide Group

Ibuprofen (Brufen®) 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.

Ibuprofen Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospital

Banhā, Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Interventions

palmidrol; Ibuprofen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Samar R Amin, M.D.

CONTACT

+201287793991; samar.rafik@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 5, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

EG (1)