Phase 4 N=22 Randomized Double-blind Treatment

Opioid Free Management After Ureteroscopy

Kidney Stone

Bottom Line

View on ClinicalTrials.gov: NCT03872843 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2021

Primary outcome: Primary: Amount of Pain Medication Used — 7.3; 6.67 tablets

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Norco 5milligram-325milligram Tablet (Drug); Ibuprofen 400 MILLIGRAM in 1 TABLET ORAL TABLET, FILM COATED (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Feb 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Amount of Pain Medication Used	7.3; 6.67	—
PRIMARY Number of Subjects Who Need Additional Pain Medication and/or Refill	0; 0	—
SECONDARY Urinary Index	29.2; 22.3	—

Summary

The purpose of this research study is to compare how well two medications work to control post-operative pain.

Eligibility Criteria

Inclusion Criteria

Ureteroscopy performed for renal stones
Age over 18 years
Two kidneys

Exclusion Criteria

Solitary Kidney
Poor kidney function (GFR<30)
Allergy to either Ibuprofen or Norco
Pelvic Kidney

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03872843). 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.