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

Trial Summary

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).

What data supports the effectiveness of the drug 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 delivered directly to the bladder during stent insertion significantly decreased pain compared to not using it. ^{1 2 3 4 5}

Is intra-nasal ketorolac safe for humans?

Research on ketorolac, including forms like drug-eluting stents and intramuscular injections, has focused on its safety and effectiveness for pain management in various conditions. Studies have generally evaluated its short-term safety, but specific data on intra-nasal use for kidney stone-related pain is limited. ^{2 4 6 7 8}

How does the drug Intra-nasal Ketorolac differ from other treatments for stent-related pain in kidney stones?

Intra-nasal Ketorolac is unique because it is administered through the nose, which can provide faster pain relief compared to traditional oral or intramuscular methods. This route of administration also allows for a more rapid onset of action, making it potentially more effective for short-term pain management in patients with stent-related pain from kidney stones. ^{2 3 4 9 10}

What is the purpose of this trial?

Objective: To improve quality-of-life and health care delivery to patients receiving ureteral stents. Specific Aims: Evaluate the feasibility, practicality, and qualitative outcomes of utilizing intra-nasal ketorolac in patients with indwelling ureteral stents (Phase I), followed by a randomized trial comparing two non-steroidal anti-inflammatory drugs, intra-nasal Ketorolac versus oral Diclofenac. Hypotheses: Due to its favorable pharmacokinetics in relieving acute pain, investigators expect improved pain scores and a lower rate of unplanned clinical encounters in patients receiving intra-nasal ketorolac compared to those taking oral diclofenac following ureteroscopic surgery for urolithiasis. Study Rationale: Following ureteroscopic management of urolithiasis, patient with indwelling ureter stents have higher levels of discomfort compared to those without a ureter stent. Prior studies showed that intramuscular Ketorolac at time of ureter stent removal decreased the incidence of unplanned clinical encounters. Furthermore, onset of analgesic effect by intra-nasal ketorolac is faster than its oral form, and similar its intramuscular and intravenous counterparts.

Research Team

Brett Johnson, MD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

The analgesic effect of ketorolac addition for renal colic pain: A meta-analysis of randomized controlled studies. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Intramuscular Ketorolac for Preventing Renal Colic Post Stent Removal: Randomized Controlled Trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

An assessment of the clinical efficacy of intranasal desmopressin spray in the treatment of renal colic. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

An in vivo porcine evaluation of the safety, bioavailability, and tissue penetration of a ketorolac drug-eluting ureteral stent designed to improve comfort. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Perioperative Ketorolac Use: A Potential Risk Factor for Renal Dysfunction After Live-Donor Nephrectomy. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

A novel drug eluting ureteral stent: a prospective, randomized, multicenter clinical trial to evaluate the safety and effectiveness of a ketorolac loaded ureteral stent. [2013]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Intranasal Desmopressin Compared with Intravenous Ketorolac for Pain Management of Patients with Renal Colic Referring to the Emergency Department: A Randomized Clinical Trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Effect of ketorolac on renal function after donor nephrectomy. [2019]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Intranasal ketorolac: for short-term pain management. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

A comparative assessment of the clinical efficacy of intranasal desmopressin spray and diclofenac in the treatment of renal colic. [2021]