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The purpose of this study is to determine if non-steroidal anti-inflammatory (NSAID) use in the postoperative setting increases the risk of acute kidney injury (AKI) in pediatric patients with mild-to-moderate chronic kidney disease (CKD). The investigators hypothesize that there is no increased risk. This is currently in the process of developing multi institution collaboration within a Pediatric Urology population, intended to inform future work in a larger patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NSAID | Experimental | Participants will receive an intravenous (IV) ketorolac 0.5mg/kg/dose, 15mg maximum, for no more than 8 doses in keeping with the investigators' routine clinical practice. Participants will then receive the oral (PO) ibuprofen suspension 10mg/kg/dose, 400mg maximum. The total duration of intervention (IV + PO) will not exceed 5 days. |
|
| Placebo | Placebo Comparator | The IV formulation will be Normal Saline. The PO formulation will be compounded to have a similar look, volume, consistency and taste to the experimental medication. Participants will receive the IV formulation for no more than 8 doses. Participants will then receive the PO formulation. The total duration of intervention (IV + PO) will not exceed 5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NSAIDs | Drug | IV formulation: ketorolac 0.5mg/kg/dose, 15mg maximum, no more than 8 doses total PO formulation: ibuprofen suspension 10mg/kg/dose, 400mg maximum Total duration (IV + PO) will not exceed 5 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Acute Kidney Injury | Acute kidney injury (AKI) will be assessed for according to Kidney Disease Improving Global Outcomes (KDIGO) criteria. Specifically, an AKI will be defined as a serum creatinine increase of ≥ 1.5 times baseline or ≥0.3 mg/dl increase within 48hrs, or a urine output <0.5ml/kg/h for 6 to 12 hours. While there are 3 stages of AKI, the investigators will consider AKI a binary outcome since all stages are managed the same clinically. Urine output is recorded as a routine part of strict intake & output monitoring by nursing. The serum creatinine will be compared to the pre-incisional/baseline data. | From start of intervention, through 14 days later |
| Measure | Description | Time Frame |
|---|---|---|
| Opiates received while inpatient | Opiate use will be calculated as morphine equivalents per day, adjusted for weight. | From start of intervention, through 7 days later |
| Days with elevated pain score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kyle Rove, MD | Contact | 7209758206 | kyle.rove@childrenscolorado.org | |
| Jennifer Pyrzanowski, MSPH | Contact | 413-329-5321 | Jennifer.pyrzanowski@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kyle Rove, MD | Children's Hospital Colorado | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Recruiting | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39089953 | Background | Ha D, Halstead NV, Blanchette ED, Wilcox DT, Vemulakonda VM, Wood DN, Rove KO. Risk of acute kidney injury after lower urinary tract reconstruction with early NSAID therapy: A propensity matched retrospective analysis. J Pediatr Urol. 2024 Oct;20(5):911-920. doi: 10.1016/j.jpurol.2024.07.005. Epub 2024 Jul 16. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| ID | Term |
|---|---|
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
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| Placebo | Drug | IV or PO medication, compounded to have similar look, consistency and taste to the corresponding medications |
|
Pain scores will be assessed using the Faces Pain Scale - Revised (FPS-R) or the visual analogue scale (VAS) depending on age, per nursing routine. The former is used for patients aged 4-8 years, and latter for patients aged 9 and older. These have previously been shown to be interchangeable. Both pain scales have a range from 0-10, with 10 being the worst. This metric will not be captured for patients under 4 years of age. The percentage of days with severe, or a pain score greater than 7 will be reported.
| From start of intervention, through hospitalization up to 5 days |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |