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Not yet recruiting NCT07316660

Palmitoylethanolamide vs Ibuprofen for Pain After ESWL

No phase Interventional Pain After Extracorporeal Shock Wave Lithotripsy Palmitoylethanolamide

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Palmitoylethanolamide (PEA), Ibuprofen (Brufen®).
Who it may be relevant to
Registry conditions: Pain After Extracorporeal Shock Wave Lithotripsy, Palmitoylethanolamide. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug 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.
  • 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.

Primary outcome measures

  • Postoperative pain intensity measured by Visual Analogue Scale (VAS) [Time frame: 2 hours after ESWL]
Secondary outcome measures (5)
  • Pain intensity over the first 24 hours after ESWL [Time frame: From recovery room arrival up to 24 hours after ESWL]
  • Time to first rescue analgesia [Time frame: Up to 24 hours after ESWL]
  • Total rescue analgesic consumption within 24 hours [Time frame: Up to 24 hours after ESWL]
  • Proportion of patients achieving clinically meaningful pain relief [Time frame: Within 24 hours after ESWL]
  • Incidence of adverse events [Time frame: From first dose of study medication up to 7 days after ESWL]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Benha University Hospital — Banhā

Identifiers

NCT: NCT07316660 · RC.19.10.2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗