Inflammatory Markers in Trauma Patient Outcomes
Condition: Polytrauma
MeSH terms: Multiple Trauma
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

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.
    

Intervention name(s): Ketorolac; Saline Solution
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive Ketorolac at 30 mg IV every 6 hours for their first 5 days of hospitalization; Participants will receive 10 ml of saline solution IV every 6 hours for their first 5 days of hospitalization
Other intervention name(s): Toradol; Normal Saline
Intervention MeSH terms: Ketorolac
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Compare the effectiveness of a NSAID to placebo in acute trauma setting.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Inflammatory cytokine; inflammation; trauma; opioid