Pain, Urinary Calculi, Urinary Stone
Conditions
Keywords
stent removal, pain, kidney stones
Brief summary
This is a prospective randomized double-blind controlled trial assessing the benefits of intramuscular ketorolac before or immediately after office ureteral stent removal.
Detailed description
Patients who are undergoing cystoscopy with ureteral stent removal at the University of Texas Southwestern Medical Center and have no contraindications to receiving ketorolac will be eligible. Patients will be randomized to receive either a 1 mL injection of ketorolac tromethamine or 1 mL injection of normal saline (0.9%) as the control arm. Ketorolac is a member of the pyrrolo-pyrrole group of non steroid anti inflammatory drugs. The mechanism of action of ketorolac, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition. The peak analgesic effect occurs within 2-3 hours. If no contraindications exist, ketorolac can be safely given to patients of any age in the 30 mg intramuscular formulation if given as a one time dose according to the package insert. Normal saline contains 0.9% of Sodium chloride in each mL. Like ketorolac, it is a clear solution and given that there are no major side effects of normal saline it is a good control for our study. It is packaged in a single dose vial that contains 100 mL. It is preservative free and stored at room temperature (20-25°C). Local pain at the injection site may occur, temporarily. The investigators will specifically look at pain scores before and after stent removal as well as narcotic medication use, telephone calls and/or emergency room visits for pain. Based on the rate of renal colic from our quality improvement project and prior work, the investigators calculated the maximum number of local subjects to be consented for this study to be n=116 (see biostatistics section). The study is expected to last 6 months.
Interventions
DRUGKetorolac
IM injection of either normal saline or Ketorolac
DRUGnormal saline
normal saline
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* patients 18 to 79 who have undergone a cystoscopy with indwelling double-J ureteral stent placement at Clements University Hospital and are presenting to the office for cystoscopy and stent removal.
Exclusion criteria
* eGFR \<50 * any active or history of peptic ulcer disease or GI bleeding * Bleeding disorder, suspected of confirmed cerebrovascular bleeding, hemorrhagic diathesis, or incomplete hemostasis * Concurrent use of Aspirin 325mg, wafarin, rivaroxaban, apixaban, clopidogrel, or heparin * Allergic reaction to NSAIDs * Concurrent use of other NSAIDs within 24 hours * Pregnancy (ketorolac contraindicated in this population) * Recent myocardial infarction (MI)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Unscheduled Return to Clinic or Emergency Room | Seven days following ureteral stent removal. | Any unscheduled in-person clinical encounter secondary to renal colic following ureteral stent removal. |
| Median Visual Analog Pain (VAS) Pain Scale Experienced by Participant 24 Hours Following Stent Removal | Twenty-four hours following ureteral stent removal. | Perceived pain on a scale of 0-10 (0= no pain, 10= worst pain ever experienced) recorded by phone call 24 hours after stent removal. |
| Number of Participants That Experienced an Injection Complication | Within thirty days post injection. | Determine if there is any infection site pain or reaction. Determine any complications related to administration of the medication. |
| Visual Analog Pain (VAS) Pain Scale 7 Days Following Stent Removal. | Seven days following ureteral stent removal. | Perceived pain on a scale of 0-10 (0= no pain, 10= worst pain ever experienced) recorded by phone call 7 days after stent removal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients That Required Opioid Medication Following Ureteral Stent Removal | Twenty-four hours following stent removal. | Determine the use of opioid medications in morphine equivalents in the 24 hours following stent removal. |
| Average Number of Days the Participant Missed Work | Seven days following stent removal. | Determine amount of missed work or school due to renal colic following ureteral stent removal. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control normal saline 0.9% | 63 |
| Ketorolac 30 mg of Ketorolac | 62 |
| Total | 125 |
Baseline characteristics
| Characteristic | Control | Ketorolac | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 16 Participants | 32 Participants |
| Age, Categorical Between 18 and 65 years | 47 Participants | 46 Participants | 93 Participants |
| Age, Continuous | 57 Years | 54 Years | 56 Years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 8 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 56 Participants | 53 Participants | 109 Participants |
| Region of Enrollment United States | 63 participants | 62 participants | 125 participants |
| Sex: Female, Male Female | 28 Participants | 31 Participants | 59 Participants |
| Sex: Female, Male Male | 35 Participants | 31 Participants | 66 Participants |
| Visual Analog Pain (VAS) Pain Scale at the baseline | 1 units on a scale | 2 units on a scale | 2 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 62 |
| other Total, other adverse events | 0 / 63 | 0 / 62 |
| serious Total, serious adverse events | 0 / 63 | 0 / 62 |
Outcome results
Primary
Median Visual Analog Pain (VAS) Pain Scale Experienced by Participant 24 Hours Following Stent Removal
Perceived pain on a scale of 0-10 (0= no pain, 10= worst pain ever experienced) recorded by phone call 24 hours after stent removal.
Time frame: Twenty-four hours following ureteral stent removal.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Median Visual Analog Pain (VAS) Pain Scale Experienced by Participant 24 Hours Following Stent Removal | 2 score on a scale |
| Ketorolac | Median Visual Analog Pain (VAS) Pain Scale Experienced by Participant 24 Hours Following Stent Removal | 1 score on a scale |
Primary
Number of Participants That Experienced an Injection Complication
Determine if there is any infection site pain or reaction. Determine any complications related to administration of the medication.
Time frame: Within thirty days post injection.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants That Experienced an Injection Complication | 1 Participants |
| Ketorolac | Number of Participants That Experienced an Injection Complication | 1 Participants |
Primary
Number of Participants With Unscheduled Return to Clinic or Emergency Room
Any unscheduled in-person clinical encounter secondary to renal colic following ureteral stent removal.
Time frame: Seven days following ureteral stent removal.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants With Unscheduled Return to Clinic or Emergency Room | 8 Participants |
| Ketorolac | Number of Participants With Unscheduled Return to Clinic or Emergency Room | 1 Participants |
Primary
Visual Analog Pain (VAS) Pain Scale 7 Days Following Stent Removal.
Perceived pain on a scale of 0-10 (0= no pain, 10= worst pain ever experienced) recorded by phone call 7 days after stent removal.
Time frame: Seven days following ureteral stent removal.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Visual Analog Pain (VAS) Pain Scale 7 Days Following Stent Removal. | 0 score on a scale (0-10, 0= no pain) |
| Ketorolac | Visual Analog Pain (VAS) Pain Scale 7 Days Following Stent Removal. | 0 score on a scale (0-10, 0= no pain) |
Secondary
Average Number of Days the Participant Missed Work
Determine amount of missed work or school due to renal colic following ureteral stent removal.
Time frame: Seven days following stent removal.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Average Number of Days the Participant Missed Work | 2.3 days of missed work | Standard Deviation 3.7 |
| Ketorolac | Average Number of Days the Participant Missed Work | 2.7 days of missed work | Standard Deviation 4.2 |
Secondary
Number of Patients That Required Opioid Medication Following Ureteral Stent Removal
Determine the use of opioid medications in morphine equivalents in the 24 hours following stent removal.
Time frame: Twenty-four hours following stent removal.
Population: Number of patients that had any opioid use at 24 hours post stent removal.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Patients That Required Opioid Medication Following Ureteral Stent Removal | 17 Participants |
| Ketorolac | Number of Patients That Required Opioid Medication Following Ureteral Stent Removal | 17 Participants |