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

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ClinicalTrials.gov Identifier: NCT03888144
Recruitment Status : Recruiting
First Posted : March 25, 2019
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Kidney Calculi Ureteral Calculi Drug: Oxycodone Drug: Ketorolac Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 13, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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




Primary Outcome Measures :
  1. Visual Analog Pain Score [ Time Frame: Daily for 5 days ]
    Averaged pain score over five days post-operatively (measured 0 to 10 mm)


Secondary Outcome Measures :
  1. Ureteric Stent Symptom Questionnaire [ Time Frame: Post-operative days 1 and 5 ]
    A validated assessment tool for stent-related symptoms and their impact on patient quality of life

  2. Medication Adverse Effects [ Time Frame: Daily for 5 days ]
    Patient-reported medication related side effects


Other Outcome Measures:
  1. Pain Medication utilization [ Time Frame: Daily for 5 days ]
    Blinded study drug daily usage or alternative over the counter pain medication utilization. Additionally the proportion of patients in each group who utilized the provided "rescue" oxycodone pills.

  2. Healthcare contact regarding refractory pain [ Time Frame: Up to Two months post-op ]
    Occurrence of contacting healthcare professionals through a phone call, office visit, physician message or emergency room visit regarding refractory pain.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03888144


Contacts
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Contact: Naveen Kachroo, MD 216-973-5227 kachron@ccf.org
Contact: Anna Faris, BA 650-200-7359 farisa2@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Rajat Jain, MD    513-255-6699    rkjain1@gmail.com   
Contact: Anna Faris, BA    650-200-7359    farisa2@ccf.org   
Principal Investigator: Sriharan Sivalingam, MD         
Sub-Investigator: Manoj Monga, MD         
Sub-Investigator: Mark Noble, MD         
Sub-Investigator: Karen Stern, MD         
Sub-Investigator: Luay Alshara, MD         
Sub-Investigator: Rajat Jain, MD         
Sub-Investigator: Naveen Kachroo, MD         
Sub-Investigator: Smita De, MD         
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Sriharan Sivalingam, MD The Cleveland Clinic
  Study Documents (Full-Text)

Documents provided by The Cleveland Clinic:

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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03888144     History of Changes
Other Study ID Numbers: 17-872
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Additional relevant MeSH terms:
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Oxycodone
Calculi
Ureteral Calculi
Ureterolithiasis
Kidney Calculi
Nephrolithiasis
Pathological Conditions, Anatomical
Ureteral Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Kidney Diseases
Ketorolac
Ketorolac Tromethamine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action