Ketorolac for Lumbar Spinal Fusion

Overseen By Sam Rudow

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Maryland St. Joseph Medical Center

Must not be taking: Narcotics, NSAIDs, Opioids

Disqualifiers: Renal failure, Cancer, Smoking, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the drug ketorolac (ketorolac tromethamine), administered through an IV, can manage pain for individuals undergoing one or two level lumbar spinal fusion surgery. The study compares ketorolac to a placebo (a harmless pill with no medicine) to determine which provides better pain relief. It targets individuals having elective spinal fusion surgery who do not have certain health issues, such as kidney problems, and are not recent smokers. As a Phase 4 trial, this research aims to understand how an already FDA-approved and effective treatment can benefit more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are actively using narcotics or have allergies to NSAIDs or opioids, you may not be eligible to participate.

What is the safety track record for Ketorolac Tromethamine?

Research has shown that ketorolac is generally safe for people after spinal surgery. One study found that patients who took ketorolac had a similar rate of major complications, about 3.7%, compared to 5.4% in those who did not take it. Minor complications were also similar, with 42.1% in the ketorolac group versus 51.7% in the other group.

Another study found that ketorolac helped manage pain after surgery and reduced the need for opioids, with few side effects. Additionally, ketorolac did not interfere with the success of spinal fusion, meaning it did not cause more problems in the healing of the spine.

Overall, these findings suggest that ketorolac is well-tolerated and safe for people undergoing spinal fusion surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for lumbar spinal fusion, which often involves opioid pain management, Ketorolac Tromethamine offers a non-opioid alternative. Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID) that targets inflammation directly, which is a key component of post-surgical pain. Researchers are excited about Ketorolac because it may reduce the reliance on opioids, potentially minimizing the risks of addiction and side effects associated with opioid use. Additionally, Ketorolac has a rapid onset of action, which could provide quicker pain relief compared to other NSAIDs.

What evidence suggests that ketorolac might be an effective treatment for lumbar spinal fusion?

Research has shown that ketorolac, which participants in this trial may receive, effectively reduces pain after lower back surgery. Studies found that patients who took ketorolac experienced less pain and required fewer strong painkillers. This is important because it helps control pain without over-relying on stronger medications. Additionally, ketorolac does not affect the success of the surgery, meaning it does not hinder proper spine healing. These findings suggest ketorolac is a reliable choice for managing pain in lower back surgeries. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for patients scheduled for one or two-level elective posterior lumbar instrumented fusion surgery. Participants must consent to the study and agree to follow-up requirements.

Inclusion Criteria

I agree to join the study and follow its requirements.

I am scheduled for elective spine surgery with hardware.

I am having a spine surgery involving one or two levels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive IV ketorolac or placebo during the post-operative period following lumbar spinal fusion

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ketorolac Tromethamine

Trial Overview

The trial is testing the effects of Ketorolac Tromethamine, an anti-inflammatory medication, against a placebo in managing post-operative pain after lumbar spinal fusion surgery. It's a double-blind study, meaning neither doctors nor patients know who gets the real drug.

How Is the Trial Designed?

Group I: Ketorolac arm Active Control 1 Intervention

Group II: Placebo Arm Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Maryland St. Joseph Medical Center

Lead Sponsor

Trials

3

Recruited

250+

Medical Metrics Diagnostics, Inc

Industry Sponsor

Trials

14

Recruited

1,800+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38224904/

The Impact of Ketorolac Utilization on Outcomes for ...

Overall, patients had similar rates of major complications (3.7% vs. 5.4%) and minor complications (42.1% vs. 51.7%) between groups after lumbar surgery.

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1878875024000548

The Impact of Ketorolac Utilization on Outcomes for ...

Overall, patients had similar rates of major complications (3.7% vs. 5.4%) and minor complications (42.1% vs. 51.7%) between groups after lumbar surgery.

3.

rheumatologyadvisor.com

rheumatologyadvisor.com/news/ketorolac-is-safe-effective-for-pain-management-following-lumbar-spine-surgery/

Ketorolac Is Safe, Effective for Pain Management Following ...

Ketorolac significantly reduced postoperative pain and opioid requirements in adults who underwent lumbar spinal surgery.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06513208

Ketorolac Effects on Post-operative Pain and Lumbar Fusion

Ketorolac use does not decrease spinal fusion rates in one or two level fusion (failure defined as by > than 2 degrees motion on standardized flexion/extension ...

5.

journals.lww.com

journals.lww.com/spinejournal/fulltext/2026/01150/postoperative_ketorolac_administration_and.2.aspx

Postoperative Ketorolac Administration and ...

Using the TriNetX database, we identified patients undergoing lumbar spinal fusion with ≥30 days of follow-up, excluding those with prior pseudoarthrosis.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6347897/

The effect of ketorolac on posterior thoracolumbar spinal ...

Ketorolac has been shown to provide quality postoperative pain control and decrease opioid requirement with minimal side effects following spinal surgery.

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1878875024000548

Literature Review The Impact of Ketorolac Utilization on ...

Overall, patients had similar rates of major complications (3.7% vs. 5.4%) and minor complications (42.1% vs. 51.7%) between groups after lumbar surgery.

8.

journals.lww.com

journals.lww.com/spinejournal/abstract/9900/postoperative_ketorolac_administration_and.1100.aspx

Postoperative Ketorolac Administration and ...

Objective. To evaluate opioid utilization and pseudoarthrosis risk following lumbar spinal fusion in patients receiving postoperative ketorolac ...

9.

thespinejournalonline.com

thespinejournalonline.com/article/S1529-9430(21)00414-9/abstract

The effect of ketorolac on posterior minimally invasive ...

Short-term use of low-dose ketorolac in patients who have undergone MIS lumbar fusion demonstrated favorable results suggesting non-inferior fusion rates.