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

86 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different doses of ketorolac, a pain-relief medication, to determine which is more effective for kidney stone pain. The goal is to compare the duration of pain relief for each dose, 15mg and 30mg, in emergency department settings. The trial seeks participants under 65 who visit the emergency department with symptoms such as flank, back, or abdominal pain and have a pain level of 4 or higher on a 0 to 10 scale. As a Phase 4 trial, it involves an FDA-approved treatment, aiming to understand its benefits for more patients.

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 is the safety track record for ketorolac?

Research has shown that ketorolac is generally safe for treating pain, including pain from kidney stones. Studies have found that ketorolac reduces pain more effectively than other pain relievers like morphine. Ketorolac is not new; the FDA has already approved it for pain management, indicating that its safety is well-understood.

Most people tolerate ketorolac well, but some might experience side effects like dizziness or an upset stomach. These side effects are usually mild and temporary. For those considering joining a trial, this research suggests that ketorolac is a well-tolerated and effective choice for managing kidney stone pain. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about ketorolac for kidney stones because it offers a non-opioid option for pain relief, which can help avoid the risk of addiction associated with opioids like morphine. Ketorolac is an anti-inflammatory drug that works by reducing inflammation and pain, making it effective for managing the intense discomfort of passing kidney stones. Unlike standard treatments that often rely on narcotics, ketorolac can provide effective pain management with potentially fewer side effects. Additionally, the study explores two different dosages, 15mg and 30mg IV, to determine the most effective dose for acute pain relief, which could lead to more tailored and effective treatment options for kidney stone sufferers.

What is the effectiveness track record for ketorolac in treating kidney stones?

This trial will compare the effectiveness of two different doses of ketorolac for relieving pain in people with kidney stones. Studies have shown that ketorolac effectively treats renal colic, providing better pain relief than opioids, another type of pain medication. Research indicates that different doses of ketorolac, such as 10 mg, 20 mg, and 30 mg, offer similar pain relief for kidney stone pain. One study confirmed that ketorolac works better than meperidine, a type of opioid, for reducing pain from kidney stones. This evidence supports using ketorolac as an effective treatment for managing pain in patients with kidney stones. ^{2 5 6 7 8}

Who Is on the Research Team?

Biren Bhatt, MD

Principal Investigator

Hackensack Meridian Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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 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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0735675720311931

The analgesic effect of ketorolac addition for renal colic pain This systematic review and meta-analysis of RCTs aims to study the analgesic efficacy of ketorolac addition in the treatment of renal colic.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12152362/

Questionable role of opioids for analgesia in renal colic ... A study in 1999 compared the efficacy of opioids and NSAIDs and reported greater pain relief in acute renal colic patients treated with ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33370510/

Comparison of intravenous ketorolac at three doses for ... There was no serious adverse event. Conclusion: Ketorolac at 10-, 20-, and 30-mg doses can produce similar analgesic efficacy in renal colic.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0735675799900037

Efficacy of ketorolac tromethamine versus meperidine in ... Ketorolac was significantly (P < .05) more effective than meperidine in reducing renal colic at 40, 60, and 90 minutes as measured on a 10-cm visual analogue ...

5. annemergmed.com annemergmed.com/article/S0196-0644(23)01300-8/fulltext

Atomized Intranasal Ketorolac Versus Intravenous ... In summary, our findings indicate that neither IN or IV ketorolac was superior to the other for the treatment of acute renal colic, and both ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK602386/

Oral Ketorolac for Renal Colic in Outpatient Settings - NCBI Oral ketorolac for the management of renal colic may reduce patients' need for opioids after discharge but it is unclear if it is clinically effective when ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5547203/

A Triple-Blind Randomized Controlled Clinical Trial - PMC Our study compared intravenous ketorolac with intravenous morphine for the treatment of acute renal colic using a randomized, controlled, triple-blinded design.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0735675723004473

Comparison of acetaminophen, ketamine, or ketorolac ... Ketorolac was the most effective in reducing the pain score at 30 and 60 min (P-score = 0.84) (P-score = 0.99), whereas morphine was the least effective (P- ...