SKOPE: Study of Ketorolac Versus Opioid for Pain After Endoscopy

Sponsor

The Cleveland Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT03888144

Collaborator

(none)

Enrollment

Location

Arms

45.6

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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

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 Design

Study Type:

Interventional

Actual Enrollment :

81 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 :

Oct 13, 2017

Actual Primary Completion Date :

Aug 1, 2021

Actual Study Completion Date :

Aug 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Visual Analog Pain Score [Daily for 5 days]
Averaged pain score over five days post-operatively (measured 0 to 10 mm)

Secondary Outcome Measures

Ureteric Stent Symptom Questionnaire [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 [Daily for 5 days]
Patient-reported medication related side effects

Other Outcome Measures

Pain Medication utilization [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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