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Study of Ketorolac Versus Opioid for Pain After Endoscopy

NCT ID: NCT03888144

Last Updated: 2025-12-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-13

Study Completion Date

2021-08-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Kidney Calculi Ureteral Calculi

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Oxycodone group

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

Group Type ACTIVE_COMPARATOR

Oxycodone

Intervention Type DRUG

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

Ketorolac group

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

Group Type EXPERIMENTAL

Ketorolac

Intervention Type DRUG

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

Interventions

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Oxycodone

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

Intervention Type DRUG

Ketorolac

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

Intervention Type DRUG

Other Intervention Names

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Toradol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sriharan Sivalingam, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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17-872

Identifier Type: -

Identifier Source: org_study_id