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This is a prospective randomized double-blind controlled trial assessing the benefits of intramuscular ketorolac before or immediately after office ureteral stent removal.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Placebo Comparator | normal saline 0.9% |
|
| Ketorolac | Active Comparator | 30 mg of Ketorolac |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac | Drug | IM injection of either normal saline or Ketorolac |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Seven days following ureteral stent removal. |
| 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. | Twenty-four hours following ureteral stent removal. |
| 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. | Within thirty days post injection. |
| 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. | Seven days following ureteral stent removal. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Twenty-four hours following stent removal. |
| Average Number of Days the Participant Missed Work |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Pearle, MD.PhD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34569278 | Derived | Johnson BA, Akhtar A, Crivelli J, Steinberg RL, Sasaki J, Street A, Antonelli JA, Pearle MS. Impact of an Enhanced Recovery After Surgery Protocol on Unplanned Patient Encounters in the Early Postoperative Period After Ureteroscopy. J Endourol. 2022 Mar;36(3):298-302. doi: 10.1089/end.2021.0435. Epub 2021 Oct 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | normal saline 0.9% normal saline: normal saline |
| FG001 | Ketorolac | 30 mg of Ketorolac Ketorolac: IM injection of either normal saline or Ketorolac |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | normal saline 0.9% |
| BG001 | Ketorolac | 30 mg of Ketorolac |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Seven days following ureteral stent removal. |
|
|
11 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | normal saline 0.9% | 0 |
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There are inherent variations in the size/location of nephrolithiasis, surgical/stent parameters, and patient characteristics that cannot be be defined or controlled.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brett Johnson | UT Southwestern Dept of Urology | 214-645-3526 | brett.johnson@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 9, 2020 | Jun 9, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D014545 | Urinary Calculi |
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D052878 | Urolithiasis |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| normal saline | Drug | normal saline |
|
|
Determine amount of missed work or school due to renal colic following ureteral stent removal. |
| Seven days following stent removal. |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Visual Analog Pain (VAS) Pain Scale at the baseline | Scale from 0 (no pain) to 10 (worst pain of one's life), describe how much pain is experienced prior to any intervetion. | Median | Inter-Quartile Range | units on a scale |
|
| Participants |
|
|
| 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. | Posted | Median | Inter-Quartile Range | score on a scale | Twenty-four hours following ureteral stent removal. |
|
|
|
| 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. | Posted | Count of Participants | Participants | Within thirty days post injection. |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | score on a scale (0-10, 0= no pain) | Seven days following ureteral stent removal. |
|
|
|
| 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. | Number of patients that had any opioid use at 24 hours post stent removal. | Posted | Count of Participants | Participants | Twenty-four hours following stent removal. |
|
|
|
| Secondary | Average Number of Days the Participant Missed Work | Determine amount of missed work or school due to renal colic following ureteral stent removal. | Posted | Mean | Standard Deviation | days of missed work | Seven days following stent removal. |
|
|
|
| 63 |
| 0 |
| 63 |
| 0 |
| 63 |
| EG001 | Ketorolac | 30 mg of Ketorolac | 0 | 62 | 0 | 62 | 0 | 62 |
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| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D006571 | Heterocyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |