Ketorolac Injection for Kidney Stones

Overseen By Karla Bergeron, CCRP

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Washington University School of Medicine

Must not be taking: NSAIDs, Steroids, Anti-inflammatories

Disqualifiers: Gastrointestinal ulcers, Ureteral obstruction, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

36 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

If you are taking chronic NSAIDs (non-steroidal anti-inflammatory drugs) or steroids, you will need to stop them to participate in this trial. However, taking a daily low-dose Aspirin (81 mg) is allowed.

What data supports the effectiveness of the drug Ketorolac Trometamol for kidney stones?

Research shows that intravenous ketorolac provided complete pain relief for a patient with kidney stones, suggesting it can be effective for managing pain in such cases. ^{1 2 3 4 5}

Is ketorolac safe for humans?

Ketorolac, a pain relief medication, can cause kidney problems and high potassium levels in the blood, especially in people with existing kidney issues. These side effects are usually reversible after stopping the medication. ^{1 2 3 6 7}

How does the drug ketorolac injection differ from other treatments for kidney stones?

Ketorolac injection is unique for kidney stones because it is a nonsteroidal anti-inflammatory drug (NSAID) that can be administered intravenously to provide rapid pain relief, unlike other treatments that may not work as quickly or effectively for acute pain. It is recommended as a first-line treatment for acute renal colic, which is the severe pain caused by kidney stones, when not contraindicated. ^{1 2 3 4 7}

What is the purpose of this trial?

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.

Research Team

Alana Desai, MD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

Adults over 18 planning to have a stent placed for kidney stones can join. They must be able to consent and not be on steroids, have GI ulcers, or liver/kidney issues. Pregnant women, those with existing stents or certain other health problems are excluded.

Inclusion Criteria

I am planning to have a stent placed in my ureter after a procedure for kidney stones.

Exclusion Criteria

I have kidney or liver problems.

I have been taking NSAIDs regularly for the last month, but I can take daily Aspirin 81 mg.

I am currently taking steroid medication.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Preoperative Treatment

Participants receive a one-time intravenous injection of Ketorolac or saline prior to the ureteroscopic procedure

1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for stent-related symptoms and complete symptom questionnaires

7 to 14 days

1 follow-up phone call, 1 visit (in-person) for stent removal

Follow-up

Participants are monitored for safety and effectiveness after stent removal

1 to 2 months

1 visit (in-person)

Treatment Details

Interventions

• Ketorolac Trometamol

Trial Overview The study is testing if Ketorolac, an anti-inflammatory drug given as an injection, can reduce symptoms after ureteral stent placement compared to a saline solution. It's also checking how easy it is to run the trial.

Participant Groups

Group I: Intervention Group - Ketorlac (NSAID) Active Control 1 Intervention

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.

Group II: Placebo Group - Normal Saline Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Findings from Research

In a case study of three patients treated with ketorolac tromethamine, two developed acute renal failure or hyperkalemia, highlighting the potential renal risks associated with this nonsteroidal anti-inflammatory drug (NSAID).

The complications were reversible in two patients after stopping the medication, emphasizing the importance of monitoring renal function in patients at risk when using ketorolac, as it can affect prostaglandin synthesis and renal vasodilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renal failure and hyperkalemia associated with ketorolac tromethamine. Pearce, CJ., Gonzalez, FM., Wallin, JD.[2022]

Ketorolac tromethamine is an effective nonsteroidal anti-inflammatory drug (NSAID) used for pain management, particularly in emergency and postoperative settings, but it can lead to acute renal failure and hyperkalemia in susceptible individuals.

In three reported cases, patients with risk factors for kidney issues developed these complications after receiving moderate doses of ketorolac, but both conditions were reversible upon stopping the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketorolac-induced acute renal failure and hyperkalemia: report of three cases. Haragsim, L., Dalal, R., Bagga, H., et al.[2019]

Intravenous ketorolac tromethamine provided complete pain relief for a 54-year-old man suffering from severe testicular pain due to a ureteral stone, after initial treatment with hydromorphone was ineffective.

The authors recommend using intravenous ketorolac as a first-line treatment for acute renal colic, highlighting its efficacy in managing pain when other medications may not work.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of ketorolac in renal colic. Di Trolio, RN., Sing, RF., Bates, GM.[2019]

In a double-blind study of 67 patients after upper abdominal surgery, ketorolac trometamol (10 mg) showed a significant reduction in potassium excretion compared to placebo, indicating a specific renal effect.

While ketorolac increased bleeding time, there were no adverse events related to this effect, suggesting it can be used safely in the postoperative setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of ketorolac trometamol on renal function. Aitken, HA., Burns, JW., McArdle, CS., et al.[2019]

Intraoperative administration of ketorolac significantly reduced the total morphine milligram equivalent (MME) requirements by 37% in patients undergoing ureteroscopy for nephrolithiasis, indicating its efficacy in pain management.

The study involved 94 patients and found that ketorolac was an independent predictor of lower narcotic use without increasing complication rates, suggesting it can be safely integrated into pain control protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toradol to Reduce Ureteroscopy Symptoms Trial (TRUST). Syed, JS., Khan, A., Van-Ryn, MG., et al.[2023]

In a review of cases, six patients experienced reversible renal insufficiency linked to short-term use of intramuscular ketorolac, with a mean recovery time of 2.3 days after stopping the medication.

The study highlights the risk of renal toxicity, particularly in patients with cardiovascular disease, suggesting that ketorolac should be used cautiously and not as a first-line pain management option in high-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renal insufficiency associated with intramuscular administration of ketorolac tromethamine. Corelli, RL., Gericke, KR.[2017]

The study found that after nasal inhalation of a radiolabelled ketorolac formulation, less than 0.5% of the dose reached the lungs, indicating minimal pulmonary deposition, regardless of the inhalation technique or posture used.

Most of the administered dose was deposited in the nasal cavity, with the best distribution observed when subjects were upright, and the drug cleared rapidly from the nasal cavity, with only 16-30% remaining after 10 minutes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary and nasal deposition of ketorolac tromethamine solution (SPRIX) following intranasal administration. Bacon, R., Newman, S., Rankin, L., et al.[2018]

References

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

Renal failure and hyperkalemia associated with ketorolac tromethamine. [2022]

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

Ketorolac-induced acute renal failure and hyperkalemia: report of three cases. [2019]

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

Use of ketorolac in renal colic. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Effects of ketorolac trometamol on renal function. [2019]

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

Toradol to Reduce Ureteroscopy Symptoms Trial (TRUST). [2023]

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

Renal insufficiency associated with intramuscular administration of ketorolac tromethamine. [2017]

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

Pulmonary and nasal deposition of ketorolac tromethamine solution (SPRIX) following intranasal administration. [2018]