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Purpose

It is unknown whether early modulation of inflammatory cytokines is associated with improved patient outcomes, reduced narcotic requirements in orthopaedic patient population, and improved patient subjective pain after hospital discharge. Preliminary animal and clinical studies have shown correlation between elevated blood cytokine concentrations during the acute phase of trauma and the development of post-traumatic complications. Early administration of nonsteroidal anti-inflammatory drug (NSAID) in animals significantly reduced inflammatory profiles, improved pulmonary edema, and enhanced arteriole vasoconstriction in response to hemorrhage. The ability to modify post-traumatic physiologic response via short-term administration of a non-steroidal anti-inflammatory drug (NSAID) may lead to improved patient outcome. In addition, given the current landscape for opioid epidemic in the United States, alternative non-opioid pain management during acute trauma has the potential to reduce opioid consumption and represents a pivotal component of multimodal analgesia strategy. By doing this study, the investigators hope to learn how to provide the best care for all patients in the state of Kentucky. Patient participation in this research will last about 1 year.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Exclusion Criteria

  • Patient age < 18 or > 65
  • Patients with injury more than 24 hours prior to evaluation
  • Hemorrhagic shock or risk of significant hemorrhage.
  • Patients with preexisting inflammatory medical condition such as inflammatory arthropathy or inflammatory bowel disease
  • Patients with acquired immunodeficiency syndrome (AIDS)
  • Patients who are pregnant
  • Patients with active GI bleed or ulceration
  • Patients with chronic use of steroids or immune modulating drugs or history of organ transplantation
  • Patients with preexisting chronic renal, liver, or lung disease
  • Patients with history of myocardial infarctions
  • Patients with chronic heart failure
  • Patients with allergy to NSAID
  • Patients with coagulation defects (Clotting factor deficiencies, thrombophilia, or any bleeding disorder)
  • Patients receiving chronic opioid therapy or treatment for opioid use disorder.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Compare the effectiveness of a NSAID to placebo in acute trauma setting.
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)
Masking Description
Participant medical team will be blinded to the treatment or placebo intervention

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Standard of Care without NSAID
Polytrauma participants will receive standard of care in addition to saline solution according to standard ATLS and standard ICU routine medical care.
  • Drug: Saline Solution
    Participants will receive 10 ml of saline solution IV every 6 hours for their first 5 days of hospitalization
    Other names:
    • Normal Saline
Experimental
Standard of Care with NSAID
Participants in the group will receive Ketorolac in addition to standard of care for the standard ATLS or ICU routine medical care.
  • Drug: Ketorolac
    Participants will receive Ketorolac at 30 mg IV every 6 hours for their first 5 days of hospitalization
    Other names:
    • Toradol

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536
Contact:
Paul Stringer, CCRP
859-218-3138
paul.stringer@uky.edu

More Details

NCT ID
NCT03671746
Status
Recruiting
Sponsor
Arun Aneja

Study Contact

Paul Stringer, CCRP
859-218-3138
Paul.stringer@uky.edu

Detailed Description

Accidental trauma is the 4th leading cause of death in the United States, and it is associated with a complex inflammatory response. This response is associated with post-traumatic complications such as; multi-organ dysfunction syndrome (MODS), bacterial pneumonia, acute respiratory distress syndrome (ARDS), systemic inflammatory response syndrome (SIRS), and post traumatic pain (PTP). It is unknown whether early modulation of inflammatory cytokines is associated with improved patient outcomes, reduced narcotic requirements, and improved patient subjective pain after hospital discharge.

Preliminary data has shown: (1) elevated blood cytokine concentrations during the acute phase of trauma are correlated with the development of fatal post-traumatic complications, (2) that early administration of a non-steroidal anti-inflammatory drug (NSAID) resulted in decreased blood serum levels of IL-6, Prostaglandin E2 (PGE2), improved pulmonary edema, and enhanced arterioles ability to vasoconstrict in response to hemorrhage in animal models, and (3) that the addition of the internal physiologic parameters (inflammatory cytokines) to New Injury Severity Score (NISS - a marker of the external anatomical insult) significantly improves the ability to predict hospital length of stay of trauma patients when compared to NISS alone. The investigator's group is the first to use an integrative approach that combines the external anatomic injury data with the internal physiologic response for accurate prediction of patient's clinical outcome. Therefore, if the investigators apply this same mindset to treatment, the investigators can improve the trauma patients' care by addressing both parameters as opposed to solely focusing on the external injury as done in the past. The ability to modify post-traumatic physiologic response via short-term administration of a NSAID may lead to improved patient outcome.

Over the last decade, clinicians remain puzzled over the safety of NSAID administration after fracture in terms of bone union. In addition, given the current landscape for opioid epidemic in the United States, alternative non-opioid pain management during acute trauma has the potential to reduce opioid consumption and represents a pivotal component of multimodal analgesia strategy.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.