Study of Ketorolac Versus Opioid for Pain After Endoscopy

The Cleveland Clinic81 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Kidney Calculi Ureteral Calculi

Interventions

OxycodoneDRUG

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

KetorolacDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Visual Analog Pain Score

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

Time frame: 5 days

Secondary Outcomes

Number of Study Pills Used

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

Time frame: Post-operative days 1 to 5

Use of Rescue Medication (Opioid)

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

Time frame: post operative day 1-5

Data from ClinicalTrials.gov

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