Ketorolac Effects on Post-operative Pain and Lumbar Fusion

NCT ID: NCT06513208

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-06-30

Brief Summary

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

Detailed Description

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Conditions

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Lumbar Spinal Fusion

Keywords

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ketorolac toradol lumbar spine fusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ketorolac arm

Group Type ACTIVE_COMPARATOR

Ketorolac Tromethamine

Intervention Type DRUG

IV Ketorolac 15mg every 6 hours, x 4 doses

Placebo Arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

IV saline as placebo

Interventions

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Ketorolac Tromethamine

IV Ketorolac 15mg every 6 hours, x 4 doses

Intervention Type DRUG

Placebo

IV saline as placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical Metrics Diagnostics, Inc

INDUSTRY

Sponsor Role collaborator

University of Maryland St. Joseph Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Maryland St. Joseph Medical Center

Towson, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Aja Janyavula

Role: CONTACT

Phone: 410-427-5459

Email: [email protected]

Sam Rudow

Role: CONTACT

Phone: 410-427-5459

Email: [email protected]

Facility Contacts

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Sam Rudow

Role: primary

Other Identifiers

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HP-00109853

Identifier Type: -

Identifier Source: org_study_id