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NCT05924165

Narcotic-Free Percutaneous Nephrolithotomy

Completed Phase 4 Results posted Last updated 26 March 2025
What this trial tests

Phase 4 trial testing 5mg Oxycodone, Q6 PRN in Nephrolithiasis in 90 participants. Completed in 7 January 2025.

Timeline
19 May 2023
Primary endpoint
7 January 2025
7 January 2025

Quick facts

Lead sponsorIcahn School of Medicine at Mount Sinai
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment90
Start date19 May 2023
Primary completion7 January 2025
Estimated completion7 January 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Icahn School of Medicine at Mount Sinai

Who can join

18 and older, any sex, with Nephrolithiasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Visual Analog Scale (VAS) Pain Scores Primary · post-op day 5 and post-op day 10

Visual Analog Scale (VAS) to measure pain: The minimum score of '0' indicates "no pain" and the maximum score of '10' indicates "Worst pain imaginable" along a line. Participants will be asked to mark the level of their pain along the line. Visual analog scale (VAS) pain scores will be recorded

post-op day 5
GroupValue95% CI
Opioid Group4.53 – 7
NSAID53 – 6
post-op day 10
GroupValue95% CI
Opioid Group10 – 2
NSAID10 – 3
Pill Count Secondary · post-op at day 10

A pill count will be conducted of each prescribed postoperative medication.

GroupValue95% CI
Opioid Group6.5± 5
NSAID12± 6
Number of Participants Who Called the Office Secondary · post-op up to day 10

Number of participants with pain related calls to the office recorded.

GroupValue95% CI
Opioid Group5
NSAID8
Number of Participants With Pain Related Visits Secondary · post-op up to day 10

Number of participants with pain related visits to the office or Emergency Department (ED) visits recorded.

GroupValue95% CI
Opioid Group3
NSAID2
Patient-related Outcome Survey (PROMIS) Scores Secondary · post-op at day 10

Patients given a survey containing questions from Patient-related outcome survey (PROMIS) instruments. A series of person-centered measures that evaluate and monitor physical, mental, and social health in adults and children. 10-item patient-reported questionnaire. standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.

GroupValue95% CI
Opioid Group107 – 13
NSAID108 – 15

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Nephrolithiasis

Currently open trials in the same condition.

Other Icahn School of Medicine at Mount Sinai trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05924165.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing