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NCT Number: NCT07316660

Palmitoylethanolamide vs Ibuprofen for Pain After ESWL

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.

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Key information

Conditions

Pain After Extracorporeal Shock Wave Lithotripsy Palmitoylethanolamide

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Postoperative pain intensity measured by Visual Analogue Scale (VAS)

    Time frame: 2 hours after ESWL

    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.

Secondary outcomes

  1. Pain intensity over the first 24 hours after ESWL

    Time frame: From recovery room arrival up to 24 hours after ESWL

    Pain intensity will be assessed using the 10-cm visual analogue scale (VAS) at predefined time points after ESWL (e.g., recovery room, 30 minutes, 1 hour, 4 hours, 6 hours, 12 hours, and 24 hours) to evaluate pain progression over time.

  2. Time to first rescue analgesia

    Time frame: Up to 24 hours after ESWL

    Time elapsed (in minutes) from completion of ESWL to the first administration of rescue analgesic medication for uncontrolled pain.

  3. Total rescue analgesic consumption within 24 hours

    Time frame: Up to 24 hours after ESWL

    Total amount of rescue analgesics administered within the first 24 hours after ESWL, recorded as grams of paracetamol and opioid consumption converted to morphine milligram equivalents (MME), if applicable.

  4. Proportion of patients achieving clinically meaningful pain relief

    Time frame: Within 24 hours after ESWL

    The proportion of participants achieving at least a 30% and 50% reduction in pain intensity on the VAS compared with baseline or peak postoperative pain.

  5. Incidence of adverse events

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

    The number and type of adverse events related to study medications, including gastrointestinal symptoms, renal-related symptoms, allergic reactions, or any other reported side effects.

Study contacts

Contact information is provided by the study sponsor or research team.

Samar R Amin, M.D.

CONTACT

[email protected]

+201287793991

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Palmitoylethanolamide Versus Ibuprofen for Acute Postoperative Pain After Extracorporeal Shock Wave Lithotripsy: A Randomized Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2026
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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