Recruiting

Ketorolac

Sponsor:

University of Maryland St. Joseph Medical Center

Code:

NCT06513208

Conditions

Lumbar Spinal Fusion

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Ketorolac Tromethamine

Placebo

Study Details

Brief summary:

A double blind prospective randomized trial of IV ketorolac vs. placebo in management of patients undergoing lumbar one or two level spinal fusions.

Conditions

Lumbar Spinal Fusion

Study ID

NCT06513208

Start date

Jan, 2026

Status verified date

Dec, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 18-85 years old (inclusive)
  • Elective posterior lumbar instrumented fusion
  • One or two level fusion
  • Consent to participate in study and willing to adhere to study follow up
  • English proficiency

Exclusion Criteria:

  • < 18 or > 85 years old
  • History of renal failure, dialysis, or creatinine over 1.50 mg/dl
  • Active or recent smoker (active within past 6 months)
  • Revision surgery
  • Auto/worker compensation
  • Active cancer or history of chemotherapy in past 6 months
  • Active narcotic use within 3 months of surgery date
  • Infection at operative levels
  • Any allergies to NSAIDs or Opioids

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Ketorolac arm

placebo comparator: Placebo Arm

Interventions

Ketorolac Tromethamine

IV Ketorolac 15mg every 6 hours, x 4 doses

Placebo

IV saline as placebo

Primary outcome measure

  • Ketorolac results in decreased post-op opioid use when administered in the first 48 hours (measured by calculating the total amount of MME utilized during the patient's inpatient stay and comparing the control and experimental groups). [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Aja Janyavula

410-427-5459ajanyavula@umm.edu

Sam Rudow

410-427-5459samuel.rudow@umm.edu

Locations

University of Maryland St. Joseph Medical Center

Recruiting

Towson, Maryland, United States, 21204

Contacts

Sam Rudow

410-427-5459samuel.rudow@umm.edu

Principal Investigator:

Justin Tortolani, MD

More Information

Sponsor

University of Maryland St. Joseph Medical Center

Last update posted

Dec 22, 2025

Last verified

Dec, 2025

Keywords

  • ketorolac
  • toradol
  • lumbar spine fusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland St. Joseph Medical Center on 2025-12-22.