NSAIDs Stent Study
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| ClinicalTrials.gov Identifier: NCT03638999 |
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Recruitment Status :
Recruiting
First Posted : August 20, 2018
Last Update Posted : March 10, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ureteral Stent Placement Kidney Stone | Drug: Ketorolac Trometamol 30Mg/1mL Injection Drug: Normal saline | Early Phase 1 |
Ureteral stent is routinely placed following ureteroscopic procedures to aid in urinary drainage post-operatively. Up to 80% of patients, however, experience stent-related symptoms (SRS) including lower abdominal pain, burning with urination, blood in urine and voiding symptoms affecting activities of their daily living. Intra- and/or post-operative therapeutic options are limited and most are initiated following the ureteral stent placement when the inflammatory process has already begun from ureteral manipulation, further limiting their efficacy. We, therefore, hypothesize that pre-operative intravenous administration of Ketorolac, with its anti-inflammatory and analgesic properties, will reduce the inflammatory process during ureteral manipulation and reduce SRS.
The eligible patients undergoing ureteral stent placement will be randomized 1:1 into either intervention or control group. Subjects in the intervention group will receive intravenous injection of 1 ml of Ketorlac 30 mg/ml, whereas subjects in the control group will receive 1 ml of 0.9% injectable normal saline, prior to the start of the procedure. A panel of plasma inflammatory markers will be drawn and assessed pre- and post-operatively as well as at the time of stent removal as an objective measures for inflammation.
A follow-up telephone call will be made by the nursing staff on post-operative day one to check on patient status and to re-educate the patients to follow the protocol.
To assess SRS, all participants will complete the AUA Symptom Score Questionnaire and the Analog Pain Scale prior to the procedure. On post-operative day 1 and at the time of stent removal (prior to the stent being taken out), participants will complete the USSQ1 and the AUA Symptom Score. At the time of subsequent follow up visit, participants will complete the USSQ2 and AUA Symptom Score.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 36 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Participants will be randomized in 1:1 ratio to either intervention or control group. Subjects in the intervention group will receive intravenous injection of 1 ml of Ketorlac 30 mg/ml, whereas subjects in the control group will receive 1 ml of 0.9% injectable normal saline, prior to the start of the procedure. Study team, with the exception of the pharmacist, will be blinded to randomization results. |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Masking Description: | Prior to initiation of study enrollment, envelopes containing study randomization assignments will be created, sequentially numbered, sealed and given to the study pharmacist. Once a patient provides consent and meets study inclusion and exclusion criteria, study pharmacist will be notified of enrollment and will randomize the patient by opening the next subsequent randomization envelope. |
| Primary Purpose: | Supportive Care |
| Official Title: | A Prospective, Randomized, Pilot Study of Preoperative Anti-Inflammatory Therapy for Ureteral Stent Symptoms |
| Actual Study Start Date : | July 31, 2018 |
| Estimated Primary Completion Date : | October 2022 |
| Estimated Study Completion Date : | October 2023 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Intervention Group - Ketorlac (NSAID)
Subjects will receive a one-time intravenous injection of 1 ml of Ketorlac 30 mg/ml prior to the start of the ureteroscopic procedure. After consent and during screening visit demographic information, medical/surgical history, and height and weight will be collected. On Day 0 subject will be randomized to NSAID or Saline using inclusion/exclusion criteria and the procedure data will be collected. On Day 1 subject will receive a follow up phone call and complete AUA Symptom Score, USS Questionnaire 1 and USS Questionnaire 2 and any adverse events will be assessed. These questionnaires will again be administered on the day of stent removal and again 1 to 2 months post stent removal.
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Drug: Ketorolac Trometamol 30Mg/1mL Injection
Subjects in the intervention group will receive intravenous injection of 1 ml of Ketorlac 30 mg/ml prior to the start of the ureteroscopic procedure.
Other Name: Toradol IV/IM |
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Placebo Comparator: Placebo Group - Normal Saline
Subjects in the control group will receive a one-time 1 ml of 0.9% injectable normal saline prior to the start of the ureteroscopic procedure. After consent and during screening visit demographic information, medical/surgical history, and height and weight will be collected. On Day 0 subject will be randomized to NSAID or Saline using inclusion/exclusion criteria and the procedure data will be collected. On Day 1 subject will receive a follow up phone call and complete AUA Symptom Score, USS Questionnaire 1 and USS Questionnaire 2 and any adverse events will be assessed. These questionnaires will again be administered on the day of stent removal and again 1 to 2 months post stent removal.
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Drug: Normal saline
Subjects in the control group will receive 1 ml of 0.9% injectable normal saline prior to the start of the ureteroscopic procedure. |
- Analog Pain Scale, 0 - 10 rating of pain - Stent insertion Day 1 [ Time Frame: Stent insertion Day 1 ]The Analog Pain Scale is a patient reported scale from 0-10 that will be administered after standard surgical procedure of ureteroscopy with or without laser lithotripsy and/or stone extraction). The Analog Pain Scale uses 0 (zero) to describe no pain and 10 will reference worst pain.
- Analog Pain Scale, 0 - 10 rating of pain - Stent removal [ Time Frame: Stent removal visit (Approximately 7 to 14 days) ]The Analog Pain Scale is a patient reported scale from 0-10 that will be administered during the stent removal visit. The Analog Pain Scale uses 0 (zero) to describe no pain and 10 will reference worst pain.
- Analog Pain Scale, 0 - 10 rating of pain - Follow-up Visit [ Time Frame: 1 to 2 months post stent removal ]The Analog Pain Scale is a patient reported scale from 0-10 that will be administered during follow up visit. The Analog Pain Scale uses 0 (zero) to describe no pain and 10 will reference worst pain.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Over 18 years of age and willing and able to provide informed consent
- Patients with renal urolithiasis planning to undergo ureteral stent placement following ureteroscopic manipulation
Exclusion Criteria:
- Patients requiring a bilateral stone procedure.
- Patients on a chronic non-steroidal anti-inflammatory drugs (NSAIDs) including Aspirin defined as any NSAIDs use for more than fifteen days within thirty days prior to the procedure. Exception: use of daily Aspirin 81 mg is allowed.
- Patients on any steroid therapy.
- Patients with prescription anti-inflammatory drugs.
- Patients with gastrointestinal ulcers.
- Patients with ureteral obstruction or stricture unrelated to stone disease.
- Patients with active urinary tract infection as evidence of untreated positive urine culture obtained prior to the procedure (as part of pre-operative testing).
- Patients with preexisting indwelling ureteral stent
- Patients who are pregnant or lactating.
- Patients with renal or liver impairment.
- Patients with concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would render the patient inappropriate for enrollment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638999
| Contact: Alana Desai, MD | (314) | desaia@email.wustl.edu | |
| Contact: Karla Bergeron, CCRP | (314) 454-7325 | bergeronk@email.wustl.edu |
| United States, Missouri | |
| Washington University | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Karla Bergeron 314-454-7325 bergeronk@email.wustl.edu | |
| Contact: Aleksandra Klim, RN, BSN (314) 747-9781 klima@wustl.edu | |
| Principal Investigator: | Alana Desai, MD | Washington University School of Medicine |
| Responsible Party: | Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT03638999 |
| Other Study ID Numbers: |
201804199 |
| First Posted: | August 20, 2018 Key Record Dates |
| Last Update Posted: | March 10, 2022 |
| Last Verified: | March 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
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Kidney Calculi Nephrolithiasis Kidney Diseases Urologic Diseases Urolithiasis Urinary Calculi Calculi Pathological Conditions, Anatomical Ketorolac Ketorolac Tromethamine Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |