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

Overseen By Isaac Palma-Zamora, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Anticoagulants, NSAIDs

Disqualifiers: Pregnancy, Solitary kidney, UTI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of an intra-nasal spray of Ketorolac (a pain reliever) compared to an oral pill called Diclofenac for managing pain in people with kidney stones who have a ureteral stent. The researchers aim to determine if the spray can more effectively reduce discomfort and unexpected doctor visits after the procedure. This trial suits individuals scheduled for kidney stone removal and stent placement. As a Phase 1, Phase 2 trial, the research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude people who are currently using anticoagulants (blood thinners) except for low-dose aspirin. It also excludes those with a contraindication to NSAIDs (non-steroidal anti-inflammatory drugs).

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using ketorolac as a nasal spray is generally safe. However, specific information about its use for kidney stone pain is limited. In past studies, this nasal spray provided effective pain relief more quickly than pills. These studies examined its short-term safety, and most participants did not report serious side effects.

For oral diclofenac, research indicates it is a commonly used non-steroidal anti-inflammatory drug (NSAID) with a well-known safety record. It has been used safely for various conditions, though some individuals might experience mild side effects like an upset stomach or dizziness.

Both treatments tested in the trial have demonstrated safety in other situations, but anyone considering joining the trial should consult their doctor to understand any personal risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about intra-nasal ketorolac for stent-related pain in kidney stones because it offers a new method of delivery that could provide faster pain relief. Unlike traditional oral NSAIDs like diclofenac, which take longer to absorb into the bloodstream, this nasal spray allows ketorolac to be absorbed quickly through the nasal passages. This could mean quicker relief from the discomfort and pain associated with ureteral stents. Additionally, the convenience of a nasal spray might improve patient adherence to pain management regimens.

What evidence suggests that this trial's treatments could be effective for stent-related pain in kidney stones?

Research has shown that ketorolac, available in different forms, can reduce pain from kidney stones and ureteral stents. In this trial, participants will receive either intranasal ketorolac or oral diclofenac at random. Intranasal ketorolac, administered through the nose, has effectively managed pain after major surgeries. This form of ketorolac works quickly, similar to injectable versions, providing fast pain relief. Studies have also found that using ketorolac during ureter stent removal can lower the chance of unexpected doctor visits. These findings suggest that intranasal ketorolac might be a promising option for easing discomfort in patients with ureteral stents. ^{2 3 4 5 6}

Who Is on the Research Team?

Brett Johnson, MD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

English-speaking

Exclusion Criteria

I have had surgery to repair my ureter.

I am unable to move around much or at all.

I currently have a urinary tract infection or sepsis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I - Pilot Study

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

5-10 days

1 visit (in-person) for stent removal

Phase II - Randomized Trial

Randomized trial comparing intranasal ketorolac to oral diclofenac following ureteroscopy and stent placement

5-10 days

1 visit (in-person) for stent removal

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain scores and unplanned clinical encounters

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intra-nasal Ketorolac
• Oral Diclofenac

Trial Overview 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.

How Is the Trial Designed?

Group I: Sprix Experimental Treatment 1 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: Diclofenac Active Control 1 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.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

assertio Therapeutics, Inc

Collaborator

Trials

1

Recruited

80+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06158620

Intra-nasal Ketorolac for Acute Ureteral Stent-associated ... Specific Aims: Evaluate the feasibility, practicality, and qualitative outcomes of utilizing intra-nasal ketorolac in patients with indwelling ureteral stents ...

2. withpower.com withpower.com/trial/phase-2-postoperative-pain-11-2023-a8cf6

Intra-nasal Ketorolac for Stent-Related Pain in Kidney Stones Research shows that ketorolac, when used in different forms, can help reduce pain associated with kidney stones and ureteral stents. For example, ketorolac ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01736358?tab=table

The Use of Intranasal Ketoralac for Pain Management (Sprix) The efficacy of intranasal ketorolac formulation was demonstrated in placebo-controlled studies in patients following major surgeries. The primary objective of ...

4. auajournals.org auajournals.org/doi/pdf/10.1097/JU.0000000000002750

Efficacy of Intramuscular Ketorolac for Preventing Renal ... Although administration of ketorolac prior to stent removal does not reduce subjective post-stent removal pain, it does reduce the likelihood ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06158620/intra-nasal-ketorolac-for-acute-ureteral-stent-associated-pain-following-ureteroscopy-for-stone-disease?page=3&id=185&slug=kidney-stones

Intra-nasal Ketorolac for Acute Ureteral Stent-associated ... Specific Aims: Evaluate the feasibility, practicality, and qualitative outcomes of utilizing intra-nasal ketorolac in patients with indwelling ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06158620

Intra-nasal Ketorolac for Acute Ureteral Stent-associated ... Specific Aims: Evaluate the feasibility, practicality, and qualitative outcomes of utilizing intra-nasal ketorolac in patients with indwelling ureteral stents ( ...