Study of Ketorolac Versus Opioid for Pain After Endoscopy (SKOPE)

Study of Ketorolac Versus Opioid for Pain After Endoscopy (SKOPE): A Double-blinded Randomized Control Trial Comparing Outpatient Analgesic Efficacy of NSAIDs and Opioids in Patients Undergoing Ureteroscopy for Kidney Stones

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.

Study Overview

• Status: Completed
• Conditions: Kidney Calculi; Ureteral Calculi
• Intervention / Treatment: Drug: Oxycodone; Drug: Ketorolac

Detailed Description

Pain is the leading cause for unplanned emergency department visits and readmissions after ureteroscopy (URS), making post-operative analgesic stewardship a priority given the current opioid epidemic. The investigators conducted a double-blinded, randomized controlled trial (RCT), with non-inferiority design, comparing nonsteroidal anti-inflammatory drugs (NSAIDs) to opiates for postoperative pain control in patients undergoing URS for urolithiasis.

Patients were randomized and blinded to either oxycodone (5mg) or ketorolac (10mg), taken as needed, with 3 non-blinded oxycodone rescue pills for breakthrough pain. Primary study outcome was visual analog scale pain score on post-operative days 1-5. Secondary outcomes included medication utilization, side effects, and Ureteral Stent Symptoms Questionnaire (USSQ) scores.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oxycodone group; Patients randomized to 20 pills of 5 mg oxycodone by mouth every 6 hours as needed for pain after ureteroscopy.	Drug: Oxycodone; 5 mg of oxycodone taken by mouth every 6 hours for 5 days
Experimental: Ketorolac group; Patients randomized to 20 pills of 10 mg ketorolac by mouth every 6 hours as needed for pain after ureteroscopy.	Drug: Ketorolac; 10 mg of ketorolac taken by mouth every 6 hours for 5 days; Other Names: Toradol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Pain Score	Patient Reported Visual Analogue Score scored from 0-10 with lower scores equaling less pain.	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Study Pills Used	the use of opioid medication as per the study protocol; Required study pills	Post-operative days 1 to 5
Use of Rescue Medication (Opioid)	the use of rescue opioid medication as per the study protocol; use of rescue medication by the patients	post operative day 1-5

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Day in Bed	number of days patient spent confined to bed post operatively	5 days
Visual Analogue Scale (VAS)	VAS as reported by the patients while in PACU (score from 0-10, with 0 meaning no pain and 10 max pain)	Up to 5 days

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Sriharan Sivalingam, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2017
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: March 14, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (Actual): March 25, 2019

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Urinary Calculi; Ureteral Diseases; Nephrolithiasis; Pathological Conditions, Signs and Symptoms; Ureterolithiasis; Kidney Calculi; Ureteral Calculi; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Indomethacin; Indoles; Heterocyclic Compounds, 4 or More Rings; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Morphine Derivatives; Codeine; Ketorolac; Ketorolac Tromethamine; Oxycodone
• Other Study ID Numbers: 17-872

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No