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Palmitoylethanolamide vs Ibuprofen for Pain After ESWL

ConditionsPain After Extracorporeal Shock Wave LithotripsyPalmitoylethanolamide
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBenha University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Palmitoylethanolamide GroupExperimental treatment 1 intervention
Group B: Ibuprofen GroupActive comparator 1 intervention

Trial outcomes

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.

Time frame
2 hours after ESWL

Secondary outcomes

1

Pain intensity over the first 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.

Time frame
From recovery room arrival up to 24 hours after ESWL
2

Time to first rescue analgesia

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

Time frame
Up to 24 hours after ESWL
3

Total rescue analgesic consumption within 24 hours

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.

Time frame
Up to 24 hours after ESWL
4

Proportion of patients achieving clinically meaningful pain relief

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.

Time frame
Within 24 hours after ESWL

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Benha University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: