Ketorolac for Kidney Stones

Overseen By Biren Bhatt, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Hackensack Meridian Health

Disqualifiers: Allergy to ketorolac, Pregnant, Renal insufficiency, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: 2

Duration: Single administration

62 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective interventional study examining the effect of ketorolac at doses of 15mg versus 30 mg for duration of analgesia in emergency department patients with suspected renal colic.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have received any pain medications within 4 hours before getting ketorolac in the emergency department.

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

The research does not provide direct evidence of Ketorolac's effectiveness for kidney stones, but it is known for its strong pain-relieving effects, which may help manage pain associated with kidney stones. However, caution is advised due to potential kidney-related side effects, especially in patients with existing kidney issues. ^{1 2 3 4 5}

Is ketorolac safe for humans?

Ketorolac, used for pain relief, can cause kidney problems like acute renal failure (sudden kidney failure) and hyperkalemia (high potassium levels in the blood), especially in people with existing risk factors. These issues were reversible after stopping the drug, but caution is advised for those with kidney concerns. ^{2 3 4 5 6}

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

Ketorolac is unique because it is a nonsteroidal anti-inflammatory drug (NSAID) that can be administered intravenously to provide effective pain relief for kidney stones, especially when other pain medications like hydromorphone fail. However, it should be used with caution in patients with kidney issues, as it can cause temporary kidney problems in some cases. ^{2 4 5 7 8}

Research Team

Biren Bhatt, MD

Principal Investigator

Hackensack Meridian Health

Eligibility Criteria

This trial is for adults under 65 who visit the emergency department with flank pain, have a pain score of at least 4 on the NRS scale, and are determined to need IV ketorolac treatment. It's specifically aimed at those suspected to have renal colic from kidney stones.

Inclusion Criteria

My pain level is 4 or higher on a scale of 0 to 10.

I am being treated with IV ketorolac.

I have pain in my side between my ribs and hip.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either 15mg or 30mg IV ketorolac to evaluate analgesic efficacy for renal colic

Single administration

1 visit (in-person)

Observation

Participants are monitored for pain reduction and need for additional rescue analgesia at 120 minutes post-administration

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

• Ketorolac

Trial Overview The study is testing two different doses of Ketorolac (15mg vs. 30mg) given intravenously to see which provides longer-lasting pain relief for patients with suspected renal colic in the emergency department setting.

Participant Groups

Group I: 15mg IV Ketorolac Active Control 1 Intervention

Patients will be randomized to 15mg IV ketorolac

Group II: 30mg IV Ketorolac Active Control 1 Intervention

Patients will be randomized to 30mg IV ketorolac

Ketorolac is already approved in United States, European Union, Switzerland for the following indications:

Approved in United States as Toradol for:

• Moderate to severe pain
• Postoperative pain
• Dysmenorrhea
• Idiopathic pericarditis
• Ocular itching

Approved in European Union as Toradol for:

• Moderate to severe pain
• Postoperative pain
• Dysmenorrhea

Approved in United States as Acular for:

• Ocular itching
• Inflammation after eye surgery

Approved in United States as Sprix for:

• Moderate to severe pain

Approved in Switzerland as Ketorolac for:

• Moderate to severe pain
• Postoperative pain

Who Is Running the Clinical Trial?

Hackensack Meridian Health

Lead Sponsor

Trials

141

Recruited

42,900+

Findings from Research

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]

A case report of a 71-year-old woman revealed that ketorolac, an NSAID, can cause acute renal failure, which had not been previously documented for this medication, highlighting its potential renal risks.

Patients with certain risk factors, such as advanced age and preexisting renal issues, are more susceptible to the renal side effects of NSAIDs like ketorolac, indicating the need for careful patient assessment before prescribing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute renal failure in an elderly woman following intramuscular ketorolac administration. Schoch, PH., Ranno, A., North, DS.[2017]

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]

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]

A case study of a 31-year-old man revealed that excessive use of ketorolac tromethamine (Acula) after PRK led to corneal ulceration and perforation, necessitating surgical intervention.

The findings highlight the importance of proper patient education regarding the use of topical NSAIDs post-surgery to prevent complications like corneal damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Corneal ulceration and perforation with ketorolac tromethamine (Acular) use after PRK. Mian, SI., Gupta, A., Pineda, R.[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 study involving over 20,000 patients treated with either parenteral ketorolac or opioids, the overall incidence of acute renal failure was low at 1.1%, indicating that both medications are relatively safe in this regard.

However, for patients receiving ketorolac for more than 5 days, there was a significant increase in the risk of acute renal failure compared to opioids, suggesting that prolonged use of ketorolac may require careful monitoring of kidney function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parenteral ketorolac: the risk for acute renal failure. Feldman, HI., Kinman, JL., Berlin, JA., et al.[2019]

References

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

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

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

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

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

Acute renal failure in an elderly woman following intramuscular ketorolac administration. [2017]

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

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

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

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

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

Corneal ulceration and perforation with ketorolac tromethamine (Acular) use after PRK. [2019]

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

Use of ketorolac in renal colic. [2019]

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

Parenteral ketorolac: the risk for acute renal failure. [2019]