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Non-steroidal Anti-inflammatory Drug

Intra-nasal Ketorolac for Stent-Related Pain in Kidney Stones

Phase 1 & 2

Waitlist Available

Led By Brett Johnson, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Candidate for unilateral ureteroscopy for treatment of urolithiasis

Surgical plan includes placement of a ureteral stent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-operative setting -the day of ureter stent removal (post-operative day 5 through 10)

Awards & highlights

Study Summary

This trial compares two drugs to improve quality-of-life & reduce unplanned visits for patients with ureteral stents.

Who is the study for?

This trial is for adults over 18 who need a ureteroscopy for kidney stones and will have a stent placed. They must speak English but can't join if they're pregnant, nursing, imprisoned, cognitively impaired, have certain kidney conditions or anatomical abnormalities, mobility issues, planned multiple surgeries, past stent complications or intolerance to NSAIDs.Check my eligibility

What is being tested?

The study aims to compare the effectiveness of intra-nasal ketorolac versus oral diclofenac in managing pain after ureteroscopic surgery with stent placement. It's expected that the nasal spray may provide faster relief and reduce unplanned hospital visits compared to the pill.See study design

What are the potential side effects?

Possible side effects include those common to NSAIDs such as stomach upset or ulcers, bleeding disorders (especially when used with other anticoagulants), allergic reactions like rashes or breathing difficulties, and potential kidney problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a candidate for a procedure to remove kidney stones using a scope.

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I am scheduled for surgery to have a ureteral stent placed.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-operative setting -the day of ureter stent removal (post-operative day 5 through 10)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-operative setting -the day of ureter stent removal (post-operative day 5 through 10)

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-operative setting -the day of ureter stent removal (post-operative day 5 through 10) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in pain scores as measured by Likert Scale Questionnaire

Change in pain scores as measured by PROMIS questionnaire

Change in pain scores as measured by USSQ Pain Survey

Secondary outcome measures

Number of unplanned clinical encounters

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SprixExperimental Treatment1 Intervention

Phase I will consist of a single-arm open label pilot study. Prior to the initiation of a large-scale randomized trial, we propose a single-arm open label pilot study to evaluate the feasibility, practicality, and qualitative outcomes of utilizing intra-nasal ketorolac in patients with indwelling ureteral stents. We seek to enroll 20 patients for the initial pilot. Phase II will consist of a randomized trial comparing intranasal ketorolac to Diclofenac, a commonly used oral NSAID. , Diclofenac potassium. Following ureteroscopy and stent placement, patients will receive standard of care medications to mitigate post operative pain and stent discomfort, and will be randomized to receive either as needed intra-nasal ketorolac or oral diclofenac. We seek to enroll and randomize 60 patients in a 1:1 fashion. Analysis will be intention to treat.

Group II: DiclofenacActive Control1 Intervention

Phase II will consist of a randomized trial comparing intranasal ketorolac to Diclofenac, a commonly used oral NSAID. , Diclofenac potassium. Following ureteroscopy and stent placement, patients will receive standard of care medications to mitigate post operative pain and stent discomfort, and will be randomized to receive either as needed intra-nasal ketorolac or oral diclofenac. We seek to enroll and randomize 60 patients in a 1:1 fashion. Analysis will be intention to treat.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

assertio Therapeutics, IncUNKNOWN

University of Texas Southwestern Medical CenterLead Sponsor

1,047 Previous Clinical Trials

1,053,719 Total Patients Enrolled

7 Trials studying Postoperative Pain

373 Patients Enrolled for Postoperative Pain

Brett Johnson, MDPrincipal InvestigatorUT Southwestern Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this clinical trial still ongoing?

"According to information on clinicaltrials.gov, this study is not accepting patients at the moment. Initially posted on December 1st 2023 and last updated November 27th 2023, it has now concluded its recruitment process; however, there are still 557 other trials that require participants currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intra-nasal Ketorolac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for Stone Disease

Brett Johnson 2024. "Intra-nasal Ketorolac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for Stone Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06158620.