NSAIDs Stent Study

NCT03638999 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 201804199
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to (1) evaluate the effect of Ketorolac on inflammatory response and its impact on stent related symptoms in patients undergoing stent placement procedure and (2) assess feasibility of recruitment, randomization, assessment procedures and implementation of the study intervention.

Conditions

Ureteral Stent Placement; Kidney Stone

Outcome Measures

Primary Outcomes (3)

• Analog Pain Scale, 0 - 10 rating of pain - 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.

  Stent insertion Day 1

• Analog Pain Scale, 0 - 10 rating of pain - Stent removal

  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.

  Stent removal visit (Approximately 7 to 14 days)

• Analog Pain Scale, 0 - 10 rating of pain - Follow-up Visit

  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.

  1 to 2 months post stent removal

Study Arms (2)

Intervention Group - Ketorlac (NSAID)

ACTIVE COMPARATOR

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.

Drug: Ketorolac Trometamol 30Mg/1mL Injection

Placebo Group - Normal Saline

PLACEBO COMPARATOR

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.

Drug: Normal saline

Interventions

Normal saline DRUG

Subjects in the control group will receive 1 ml of 0.9% injectable normal saline prior to the start of the ureteroscopic procedure.

Placebo Group - Normal Saline

Ketorolac Trometamol 30Mg/1mL Injection DRUG

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.

Also known as: Toradol IV/IM

Intervention Group - Ketorlac (NSAID)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

Related Publications (8)

• Assimos D, Krambeck A, Miller NL, Monga M, Murad MH, Nelson CP, Pace KT, Pais VM Jr, Pearle MS, Preminger GM, Razvi H, Shah O, Matlaga BR. Surgical Management of Stones: American Urological Association/Endourological Society Guideline, PART II. J Urol. 2016 Oct;196(4):1161-9. doi: 10.1016/j.juro.2016.05.091. Epub 2016 May 27.

  PMID: 27238615 BACKGROUND

• Joshi HB, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG, Barry MJ. Indwelling ureteral stents: evaluation of symptoms, quality of life and utility. J Urol. 2003 Mar;169(3):1065-9; discussion 1069. doi: 10.1097/01.ju.0000048980.33855.90.

  PMID: 12576847 BACKGROUND

• Lamb AD, Vowler SL, Johnston R, Dunn N, Wiseman OJ. Meta-analysis showing the beneficial effect of alpha-blockers on ureteric stent discomfort. BJU Int. 2011 Dec;108(11):1894-902. doi: 10.1111/j.1464-410X.2011.10170.x. Epub 2011 Mar 31.

  PMID: 21453351 BACKGROUND

• Norris RD, Sur RL, Springhart WP, Marguet CG, Mathias BJ, Pietrow PK, Albala DM, Preminger GM. A prospective, randomized, double-blinded placebo-controlled comparison of extended release oxybutynin versus phenazopyridine for the management of postoperative ureteral stent discomfort. Urology. 2008 May;71(5):792-5. doi: 10.1016/j.urology.2007.11.004. Epub 2008 Mar 12.

  PMID: 18339420 BACKGROUND

• De Oliveira GS Jr, Agarwal D, Benzon HT. Perioperative single dose ketorolac to prevent postoperative pain: a meta-analysis of randomized trials. Anesth Analg. 2012 Feb;114(2):424-33. doi: 10.1213/ANE.0b013e3182334d68. Epub 2011 Sep 29.

  PMID: 21965355 BACKGROUND

• Elwood CN, Lange D, Nadeau R, Seney S, Summers K, Chew BH, Denstedt JD, Cadieux PA. Novel in vitro model for studying ureteric stent-induced cell injury. BJU Int. 2010 May;105(9):1318-23. doi: 10.1111/j.1464-410X.2009.09001.x. Epub 2009 Nov 3.

  PMID: 19888977 BACKGROUND

• Beiko DT, Watterson JD, Knudsen BE, Nott L, Pautler SE, Brock GB, Razvi H, Denstedt JD. Double-blind randomized controlled trial assessing the safety and efficacy of intravesical agents for ureteral stent symptoms after extracorporeal shockwave lithotripsy. J Endourol. 2004 Oct;18(8):723-30. doi: 10.1089/end.2004.18.723.

  PMID: 15659891 BACKGROUND

• Krambeck AE, Walsh RS, Denstedt JD, Preminger GM, Li J, Evans JC, Lingeman JE; Lexington Trial Study Group. A novel drug eluting ureteral stent: a prospective, randomized, multicenter clinical trial to evaluate the safety and effectiveness of a ketorolac loaded ureteral stent. J Urol. 2010 Mar;183(3):1037-42. doi: 10.1016/j.juro.2009.11.035. Epub 2010 Jan 21.

  PMID: 20092835 BACKGROUND

MeSH Terms

Conditions

Kidney Calculi

Interventions

Ketorolac; Injections; Saline Solution

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Alana Desai, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alana Desai, MD

CONTACT

(314); desaia@email.wustl.edu

Karla Bergeron, CCRP

CONTACT

(314) 454-7325; bergeronk@email.wustl.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 20, 2018
• Study Start: July 31, 2018
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

US (1)