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Trial record 54 of 469 for:    KETOROLAC

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

Tracking Information
First Submitted Date  ICMJE March 14, 2019
First Posted Date  ICMJE March 25, 2019
Last Update Posted Date March 25, 2019
Actual Study Start Date  ICMJE October 13, 2017
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
Visual Analog Pain Score [ Time Frame: Daily for 5 days ]
Averaged pain score over five days post-operatively (measured 0 to 10 mm)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
  • 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
  • Medication Adverse Effects [ Time Frame: Daily for 5 days ]
    Patient-reported medication related side effects
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 21, 2019)
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study of Ketorolac Versus Opioid for Pain After Endoscopy
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Kidney Calculi
  • Ureteral Calculi
Intervention  ICMJE
  • Drug: Oxycodone
    5 mg of oxycodone taken by mouth every 6 hours for 5 days
  • Drug: Ketorolac
    10 mg of ketorolac taken by mouth every 6 hours for 5 days
Study Arms  ICMJE
  • Active Comparator: Oxycodone group
    Patients randomized to 20 pills of 5 mg oxycodone by mouth every 6 hours as needed for pain after ureteroscopy.
    Intervention: Drug: Oxycodone
  • Experimental: Ketorolac group
    Patients randomized to 20 pills of 10 mg ketorolac by mouth every 6 hours as needed for pain after ureteroscopy.
    Intervention: Drug: Ketorolac
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 21, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Naveen Kachroo, MD 216-973-5227 kachron@ccf.org
Contact: Anna Faris, BA 650-200-7359 farisa2@ccf.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03888144
Other Study ID Numbers  ICMJE 17-872
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sriharan Sivalingam, MD The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP