Palmitoylethanolamide vs Ibuprofen for Pain After ESWL
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
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
Treatments tested in this trial
- Palmitoylethanolamide (PEA)
- Ibuprofen (Brufen®)
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov