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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From recovery room arrival up to 24 hours after ESWL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samar R Amin, M.D. | Contact | +201287793991 | samar.rafik@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benha University Hospital | Banhā | Qalyubia Governorate | 13511 | Egypt |
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| ID | Term |
|---|---|
| C005958 | palmidrol |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| 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. |
|
| Time to first rescue analgesia |
Time elapsed (in minutes) from completion of ESWL to the first administration of rescue analgesic medication for uncontrolled pain. |
| Up to 24 hours after ESWL |
| 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. | Up to 24 hours after ESWL |
| 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. | Within 24 hours after ESWL |
| Incidence of adverse events | 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. | From first dose of study medication up to 7 days after ESWL |