CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 70 enrolled
Drug / intervention
Ketorolac +1 moredrug
Likely dose
Ketorolac 15 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03671746
NCT03671746Phase 1Completed

Inflammatory Response to Trauma - Does Early Cytokine Modulation Improve Patient Outcome

Arun Aneja·interventional·Posted Sep 14, 2018·Updated Jun 5, 2025

In Brief

A Phase 1 clinical trial evaluating Ketorolac and Saline Solution for Polytrauma. Completed, enrolled 70 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolytrauma
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedSep 14, 2018
Enrollment StartFeb 28, 2019
Primary CompletionJun 20, 2023
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 7.8 years ago

Interventions

Ketorolacdrug

Participants will receive Ketorolac at 15 mg IV every 6 hours for their first 5 days of hospitalization

Saline Solutiondrug

Participants will receive 1 ml of saline solution IV every 6 hours for their first 5 days of hospitalization