Study of Ketorolac Versus Opioid for Pain After Endoscopy

NCT03888144 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 17-872
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Calculi; Ureteral Calculi

Outcome Measures

Primary Outcomes (1)

• Visual Analog Pain Score

  Patient Reported Visual Analogue Score scored from 0-10 with lower scores equaling less pain.

  5 days

Secondary Outcomes (2)

• Number of Study Pills Used

  Post-operative days 1 to 5

• Use of Rescue Medication (Opioid)

  post operative day 1-5

Other Outcomes (2)

• Day in Bed

  5 days

• Visual Analogue Scale (VAS)

  Up to 5 days

Study Arms (2)

Oxycodone group

ACTIVE COMPARATOR

Patients randomized to 20 pills of 5 mg oxycodone by mouth every 6 hours as needed for pain after ureteroscopy.

Drug: Oxycodone

Ketorolac group

EXPERIMENTAL

Patients randomized to 20 pills of 10 mg ketorolac by mouth every 6 hours as needed for pain after ureteroscopy.

Drug: Ketorolac

Interventions

Oxycodone DRUG

5 mg of oxycodone taken by mouth every 6 hours for 5 days

Oxycodone group

Ketorolac DRUG

10 mg of ketorolac taken by mouth every 6 hours for 5 days

Also known as: Toradol

Ketorolac group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Kidney Calculi; Ureteral Calculi

Interventions

Oxycodone; Ketorolac; Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Ureterolithiasis; Ureteral Diseases

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring

Limitations and Caveats

This study has limitations: medication adherence and symptom scores relied on self-reporting; some patients had early stent removal or were lost to follow-up; the population excluded sicker patients; and most were Caucasian at a tertiary center, limiting generalizability.

Results Point of Contact

• Title: Dr Sriharan Sivalingam
• Organization: Cleveland Clinic foundation

SIVALIS@ccf.org

2162130159

Study Officials

• Sriharan Sivalingam, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 25, 2019
• Study Start: October 13, 2017
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: December 23, 2025
• Results First Posted: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)