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Ketorolac Effects on Post-operative Pain and Lumbar Fusion

ConditionLumbar Spinal Fusion
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Maryland St. Joseph Medical Center

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

< 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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ketorolac Tromethamine

    Drug

    IV Ketorolac 15mg every 6 hours, x 4 doses

  • Placebo

    Drug

    IV saline as placebo

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Ketorolac armActive comparator 1 intervention
Group B: Placebo ArmPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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 x-rays compared to pre-op imaging analyzed by SpineCAMP software at 6 and 12 months post-op).

Time frame
12 months
2

Ketorolac use decreases average length of hospital stay (length of stay for both the control group and the experimental group will be counted, and a statistical average for each group will be calculated and compared).

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Maryland St. Joseph Medical Center

Lead sponsor

Medical Metrics Diagnostics, Inc

Collaborator

Source ClinicalTrials.gov
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