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Completed

NCT Number: NCT03888144

Study of Ketorolac Versus Opioid for Pain After Endoscopy

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxycodone

Drug

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

Ketorolac

Drug

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

Other names: Toradol

Primary outcomes

  1. Visual Analog Pain Score

    Time frame: 5 days

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

Secondary outcomes

  1. Number of Study Pills Used

    Time frame: Post-operative days 1 to 5

    the use of opioid medication as per the study protocol; Required study pills

  2. Use of Rescue Medication (Opioid)

    Time frame: post operative day 1-5

    the use of rescue opioid medication as per the study protocol; use of rescue medication by the patients

Other outcomes

  1. Day in Bed

    Time frame: 5 days

    number of days patient spent confined to bed post operatively

  2. Visual Analogue Scale (VAS)

    Time frame: Up to 5 days

    VAS as reported by the patients while in PACU (score from 0-10, with 0 meaning no pain and 10 max pain)

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Acronym: SKOPE

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 25, 2019
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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