Phase 1 N=70 Randomized Triple-blind Treatment

Inflammatory Markers in Trauma Patient Outcomes

Polytrauma

Bottom Line

View on ClinicalTrials.gov: NCT03671746 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2025

Primary outcome: Primary: Length of Hospital Stay — 7; 8 days — p==0.275

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Ketorolac (Drug); Saline Solution (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Arun Aneja
Primary completion: Jun 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Length of Hospital Stay	7; 8	=0.275
SECONDARY Morphine Milligram Equivalents in House	82.5; 86; 67.75; 48.75; 62; 53	<0.05 sig
SECONDARY Change in Patient Pain Scores	55.1; 68.2; 52.2; 42.7; 53.9; 47.4	<0.05 sig
SECONDARY Change in Interleukin 1a	115.1; 138.8; 112.7; 122.6; 119.3; 135.4	=0.564
SECONDARY Change in Interleukin 1b	0.119; 0.119; 0.095; 0.130; 0.084; 0.118	=0.118
SECONDARY Change in Interleukin 6	21.5; 20.6; 21.2; 14.6; 16.3; 11.9	0.215
SECONDARY Change in Interleukin 10	1.10; 1.11; 0.90; 0.76; 0.57; 0.62	=0.043 sig
SECONDARY Change in Prostaglandin E-2	352.2; 448.3; 477.0; 375.8; 345.8; 356.6	=0.617
SECONDARY Post Traumatic Complications	4; 3; 2; 0	—
SECONDARY Mortality	0; 0	<0.05 sig
SECONDARY Change in Inpatient Subjective Pain Reports	55.1; 68.2; 52.2; 42.7; 53.9; 47.4	—
SECONDARY Change in Outpatient Subjective Pain Reports	-22.7; -16.7	—

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.

Eligibility Criteria

Inclusion Criteria

Patients age 18 to 75
New Injury Severity Score (NISS) > 9, with musculoskeletal injury requiring surgical treatment

Exclusion Criteria

Patient age 75
Patients who presented more than 24 hours after time of injury
Patients with contraindications to NSAID therapy (i.e., patients with active hemorrhage, received blood products, traumatic brain injury (TBI), active gastrointestinal bleeding or ulceration, NSAID allergy, thromboembolism, or coagulopathy)
Patients with pre-existing inflammatory condition (e.g., inflammatory arthropathy or bowel disease)
Patients with preexisting immunocompromised/immunosuppressed condition or acquired immunodeficiency syndrome (AIDS)
Patients with pre-existing comorbidities (e.g., coronary artery disease, myocardial infarction, chronic organ failure, chronic obstructive pulmonary disease, emphysema, asthma, etc.)
Patients with chronic use of steroids, immuno-modulating drugs, or history of organ transplantation
Patients receiving chronic opioid therapy or treatment for opioid use disorder
Patients who are pregnant
Patients with thermal injury

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03671746). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.