A Phase 4 interventional study of Ibuprofen (Brufen®) and Paracetamol (drug) in Urolithiasis, Kidney Stones and Ureteral Stones, sponsored by University of Gaziantep. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by University of Gaziantep · Phase 4, Interventional, and Treatment
This prospective randomized controlled trial aims to compare the analgesic efficacy of three non-opioid analgesics (ibuprofen, paracetamol, and tenoxicam) during extracorporeal shock wave lithotripsy (ESWL). All patients undergoing ESWL will be randomly assigned into four groups including a placebo group.
Pain intensity will be assessed using the Visual Analog Scale (VAS) at the 5th, 10th, 15th, and 20th minutes during the procedure. In addition to comparing analgesic efficacy, the study will evaluate patient-related and stone-related factors affecting pain perception, including body mass index, subcutaneous fat thickness, and stone density measured by Hounsfield Units.
The study also aims to assess the relationship between analgesic efficacy, energy levels applied during ESWL, and treatment outcomes such as stone-free rates. The findings may contribute to optimizing individualized pain management strategies and improving treatment efficiency in ESWL procedures.
Extracorporeal shock wave lithotripsy (ESWL) is a widely used non-invasive treatment modality for urinary stone disease. Despite its minimally invasive nature, ESWL can cause significant pain due to the transmission of shock waves through skin, soft tissues, and renal structures. Inadequate pain control may lead to patient movement, reduced tolerance, and suboptimal targeting of the stone, ultimately affecting treatment success.
This prospective randomized controlled study is designed to compare the analgesic efficacy of three commonly used non-opioid analgesics-ibuprofen, paracetamol, and tenoxicam-against placebo during ESWL. All patients will be included and randomly assigned into four equal groups using a computer-generated randomization method.
Pain intensity will be evaluated using the Visual Analog Scale (VAS) at predefined time points (5th, 10th, 15th, and 20th minutes) during the ESWL procedure. The primary objective is to determine differences in pain control among the analgesic groups.
Secondary objectives include evaluating the association between pain intensity and procedural parameters such as energy levels applied during ESWL, as well as patient-related and stone-related factors. These include body mass index (BMI), subcutaneous fat thickness, and stone density measured in Hounsfield Units (HU).
In addition, treatment success will be assessed by stone-free rates, and the relationship between effective analgesia and the ability to apply higher energy levels will be analyzed.
The study hypothesizes that improved analgesia may enhance patient tolerance, allow the application of higher energy levels, and consequently improve stone fragmentation and treatment outcomes.
The results of this study may provide clinically relevant insights for optimizing analgesic protocols and individualizing patient management during ESWL procedures.
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
This study's planned enrollment of 160 is above the median of 86 across 391 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →University of Gaziantep is the lead sponsor of 105 studies on the registry; 28 are open to participants now.
Compared within Kidney Calculi, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Urolithiasis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Known or to ibuprofen, paracetamol, or tenoxicam
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive ibuprofen prior to ESWL for pain control.
Drug: Ibuprofen (Brufen®)
Participants receive paracetamol prior to ESWL for pain control.
Drug: Paracetamol (drug)
Participants receive tenoxicam prior to ESWL for pain control.
Drug: Placebo
Participants receive placebo prior to ESWL.
Drug: Tenoxicam
Ibuprofen administered prior to ESWL for pain control.
Paracetamol administered prior to ESWL for pain control.
Tenoxicam administered prior to ESWL for pain control.
Placebo administered prior to ESWL.
Pain Intensity During Extracorporeal Shock Wave Lithotripsy (ESWL) Measured by Visual Analog Scale (VAS)
Pain intensity will be assessed using the Visual Analog Scale (VAS), with scores ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be recorded at the 5th, 10th, 15th, and 20th minutes during the ESWL procedure. Higher scores indicate greater pain intensity and therefore a worse outcome. VAS scores will be compared between treatment groups.
Time frame: During ESWL procedure (up to 20 minutes)
Stone-Free Rate After Extracorporeal Shock Wave Lithotripsy (ESWL)
Stone-free status will be defined as the absence of residual stone fragments on imaging performed 2 to 4 weeks after ESWL. The proportion of participants who are stone-free will be compared between treatment groups.
Time frame: Within 2-4 weeks after ESWL
Plan to share: Undecided — Individual participant data (IPD) sharing is currently undecided. Data may be shared upon reasonable request after publication, in accordance with institutional policies and ethical considerations.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ibuprofen · Acetaminophen