Phase 4 N=81 Randomized Quadruple-blind Treatment

Study of Ketorolac Versus Opioid for Pain After Endoscopy

Kidney Calculi · Ureteral Calculi

Bottom Line

View on ClinicalTrials.gov: NCT03888144 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2025

Primary outcome: Primary: Visual Analog Pain Score — 4.6; 4.5 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Oxycodone (Drug); Ketorolac (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Cleveland Clinic
Primary completion: Aug 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Visual Analog Pain Score	4.6; 4.5	—
SECONDARY Number of Study Pills Used	7.3; 7.1	—
SECONDARY Use of Rescue Medication (Opioid)	1.1; 0.8	—

Summary

A double blind randomized controlled trial designed to compare pain control and safety with ketorolac and oxycodone in the post-operative setting for patients undergoing ureteroscopy for treatment of urinary stones. Patients are followed for five days after their surgery as they record their pain scores, medication utilization, and stent related symptoms.

Eligibility Criteria

Inclusion Criteria

Patients with kidney or ureteral stones confirmed on imaging (CT of the abdomen pelvis) and who elect for definitive treatment via unilateral ureteroscopy at one of two hospital sites within a tertiary care institution
Patients who post-operatively receive a unilateral ureteral stent
Capable of giving informed consent
Capable and willing to fulfill requirements of the study

Exclusion Criteria

Active or history of peptic ulcer disease, gastrointestinal bleeding or perforation
History of coronary artery bypass graft surgery
History of a bleeding disorder
GFR less than 60 mL/min/1.73m2 (MDRD equation)
Chronic use of opioid or other pain medication including NSAIDs (greater than 12 weeks)
Known allergy to either ketorolac or oxycodone
Known or suspected pregnancy
Solitary kidney
Patients taking anticoagulant medication or antiplatelet medication (e.g. warfarin, clopidogrel, pradaxa, rivaroxaban, apixaban etc).
Inability to give informed consent or unable to meet requirements of the study for any reason

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03888144). 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.