Phase 4 N=90 Randomized Single-blind Treatment

Narcotic-Free Percutaneous Nephrolithotomy

Nephrolithiasis

Bottom Line

View on ClinicalTrials.gov: NCT05924165 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcome: Primary: Visual Analog Scale (VAS) Pain Scores — 4.5; 5; 1; 1 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: 5mg Oxycodone, Q6 PRN (Drug); 10mg Ketorolac, Q6 PRN (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Icahn School of Medicine at Mount Sinai
Primary completion: Jan 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Visual Analog Scale (VAS) Pain Scores	4.5; 5; 1; 1	—
SECONDARY Pill Count	6.5; 12	—
SECONDARY Number of Participants Who Called the Office	5; 8	—
SECONDARY Number of Participants With Pain Related Visits	3; 2	—
SECONDARY Patient-related Outcome Survey (PROMIS) Scores	10; 10	—

Summary

This is a randomized control trial comparing oral ketorolac and opioid medication for the use of post-operative analgesia.

Eligibility Criteria

Inclusion Criteria

Undergoing scheduled unilateral standard (24Fr), PCNL with at least 2cm stone burden, with expected single access

Exclusion Criteria

Pregnant women
History of chronic opioid abuse
Allergy, hypersensitivity, or other contraindication to NSAID usage such as
eGFR < 60 mL/min
Peptic ulcer disease or history of gastric bypass
Concurrent use of antiplatelet or anticoagulation therapy (including aspirin)
Thrombocytopenia
Suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis, and those at high risk of bleeding.
Concomitant medications:
Other NSAIDs
Antiplatelet or anticoagulation medications
Probenecid
Pentoxifylline
Allergy, hypersensitivity, or other contraindication to opioids:
Current opioid prescription/usage for any reason, including active treatment with suboxone or methadone
Respiratory depression
Patients with acute or severe bronchial asthma or hypercarbia
Patients who have or is suspected of having paralytic ileus as PCNL done under general anesthesia
Patients with hepatic Impairment
Concomitant medications:
Monoamine Oxidase Inhibitors (MAOIs)
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
Diagnosis of chronic pain disorder
Reduced sensation of abdomen or pelvis (e.g. patients with spinal cord injury)
Pre-existing stent or nephrostomy tube
Urinary tract anomalies such as urinary diversion, horseshoe kidney, solitary kidney, urinary stricture disease, ureteropelvic junction obstruction, pelvic kidney, stone in calyceal diverticulum)
Pulmonary disease
Liver disease
Seizure disorders
Subjects taking nephrotoxic medications
Subjects taking medications that can increase sedation risk (benzodiazepines or other sedative hypnotics)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05924165). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.