PolytraumaPhase 1NCT03671746
Inflammatory Markers in Trauma Patient Outcomes
A Phase 1 study testing Ketorolac and Saline Solution in people with Polytrauma, run by Arun Aneja at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Polytrauma
- What is being tested?
- Ketorolac and Saline Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2019to 20 Jun 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age 18 to 75
- New Injury Severity Score (NISS) > 9, with musculoskeletal injury requiring surgical treatment
Who cannot join
- Patient age < 18 or > 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.)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inflammatory Response to Trauma - Does Early Cytokine Modulation Improve Patient Outcome
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.
Read the 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 interleukin (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 a 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 an NSAID may lead to improved patient outcomes.
Over the last decade, clinicians have remained puzzled over the safety of NSAID administration after fracture in terms of bone union. In addition, given the current landscape for the 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.
- Conditions
- Polytrauma
- Being tested
- Ketorolac, Saline Solution
- Keywords
- Inflammatory cytokine, inflammation, trauma, opioid
- Medical subject headings
- Multiple Trauma, Inflammation, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
Also called Toradol
Participants will receive Ketorolac at 15 mg IV every 6 hours for their first 5 days of hospitalization
Saline SolutionDrug
Also called Normal Saline
Participants will receive 1 ml of saline solution IV every 6 hours for their first 5 days of hospitalization
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care without NSAID | Placebo comparator | Polytrauma participants will receive standard of care in addition to saline solution according to standard Advanced Trauma Life Support (ATLS) and standard ICU routine medical care. Receives: Drug: Saline Solution |
| Standard of Care with NSAID | Experimental | Participants in the group will receive Ketorolac in addition to standard of care for the standard Advanced Trauma Life Support (ATLS) and standard ICU routine medical care. Receives: Drug: Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospital Stay
Duration of the hospital stay will be calculated from electronic health record
Measured: Up to 30 days
Secondary outcomes (11)
Morphine Milligram Equivalents in House
The the morphine milligram equivalents (MME) will be recorded throughout the course of the hospital stay. These will be reported as daily totals.
Measured: Hospital Day 0 (Enrollment), Day 1, Day 2, Day 3, Day 4, Day 5
Change in Patient Pain Scores
The patient reported pain scores (visual analogue pain scores) will be recorded throughout the course of the hospital stay. The scores are reported by the patients and range from 0 indicating no pain to 100 meaning the worst pain imaginable. These will be reported as daily averages.
Measured: Hospital Day 0 (Enrollment), Day 1, Day 2, Day 3, Day 4, Day 5
Change in Interleukin 1a
Daily blood collections during the first 5 days of hospitalization. Interleukin 1a will be measured by the sandwich ELISA, and data will be presented as change in the baseline level of Interleukin 1 from presentation to the emergency room to day 5 of hospitalization.
Measured: Hospital Day 0 (Enrollment), Day 1, Day 2, Day 3, Day 4, Day 5
Change in Interleukin 1b
Daily blood collections during the first 5 days of hospitalization. Interleukin 1b will be measured by the sandwich ELISA, and data will be presented as change in the baseline level of Interleukin 1 from presentation to the emergency room to day 5 of hospitalization.
Measured: Hospital Day 0 (Enrollment), Day 1, Day 2, Day 3, Day 4, Day 5
Change in Interleukin 6
Daily blood collections during the first 5 days of hospitalization. Interleukin 6 will be measured by the sandwich ELISA, and data will be presented as change in the baseline level of Interleukin 6 from presentation to the emergency room to day 5 of hospitalization.
Measured: Hospital Day 0 (Enrollment), Day 1, Day 2, Day 3, Day 4, Day 5
Change in Interleukin 10
Daily blood collections during the first 5 days of hospitalization. Interleukin 10 will be measured by the sandwich ELISA, and data will be presented as change in the baseline level of Interleukin 10 from presentation to the emergency room to day 5 of hospitalization.
Measured: Hospital Day 0 (Enrollment), Day 1, Day 2, Day 3, Day 4, Day 5
Change in Prostaglandin E-2
Blood will be collected over the course of 5 days of hospitalization. Prostaglandin E-2 will be measured by the sandwich ELISA, and data will be presented as change in the baseline level of Prostaglandin E-2 from presentation to the emergency room to day 5 of hospitalization
Measured: Hospital Day 0 (Enrollment), Day 1, Day 2, Day 3, Day 4, Day 5
Post Traumatic Complications
The Incidence of post-traumatic complications in the patients which includes, but is not limited to the occurrence of pulmonary complications (i.e., bacterial pneumonia, pulmonary edema, acute respiratory failure) and AKI will be recorded throughout the duration of the hospital stay, usually up to 30 days. Data will be presented as the percentage of participants with a diagnosed post-traumatic complication.
Measured: Up to 30 days
Mortality
The Incidence of death related to the initial trauma/traumatic complications will be recorded for the first 30 days.
Measured: Up to 30 days
Change in Inpatient Subjective Pain Reports
The patient reported pain scores (visual analogue pain scores) will be recorded throughout the course of the hospital stay. The scores are reported by the patients and range from 0 indicating no pain to 100 meaning the worst pain imaginable. These will be reported as daily averages.
Measured: Hospital Day 0 (Enrollment), Day 1, Day 2, Day 3, Day 4, Day 5
Change in Outpatient Subjective Pain Reports
Patient reports of level of pain and how much it inhibits their daily activities will be recorded in the outpatient setting. The scores are reported by the patients (visual analogue scale) and range from 0 indicating no pain to 100 meaning the worst pain imaginable. This will be reported for each patient follow-up visit. Several visits are possible and data will only be collected for the first year of follow-up. Data presented as the change in subject pain from baseline to 365 days.
Measured: up to 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start28 Feb 2019
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (104)Papers the sponsor has linked to this study.
- Other trials for PolytraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Compare the effectiveness of a NSAID to placebo in acute trauma setting.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arun Aneja
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Arun Aneja, University of Kentucky
- Investigators
- Arun Aneja, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671746
- Sponsor's protocol ID
- 43611
- Status last verified
- Jun 2025
- First submitted
- 12 Sep 2018
- Last updated
- 5 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Braden JB, Fan MY, Edlund MJ, Martin BC, DeVries A, Sullivan MD. Trends in use of opioids by noncancer pain type 2000-2005 among Arkansas Medicaid and HealthCore enrollees: results from the TROUP study. J Pain. 2008 Nov;9(11):1026-35. doi: 10.1016/j.jpain.2008.06.002. Epub 2008 Jul 26.
PubMed 18676205Lawal OD, Gold J, Murthy A, Ruchi R, Bavry E, Hume AL, Lewkowitz AK, Brothers T, Wen X. Rate and Risk Factors Associated With Prolonged Opioid Use After Surgery: A Systematic Review and Meta-analysis. JAMA Netw Open. 2020 Jun 1;3(6):e207367. doi: 10.1001/jamanetworkopen.2020.7367.
PubMed 32584407Mohamadi A, Chan JJ, Lian J, Wright CL, Marin AM, Rodriguez EK, von Keudell A, Nazarian A. Risk Factors and Pooled Rate of Prolonged Opioid Use Following Trauma or Surgery: A Systematic Review and Meta-(Regression) Analysis. J Bone Joint Surg Am. 2018 Aug 1;100(15):1332-1340. doi: 10.2106/JBJS.17.01239.
PubMed 30063596Bosse MJ, MacKenzie EJ, Kellam JF, Burgess AR, Webb LX, Swiontkowski MF, Sanders RW, Jones AL, McAndrew MP, Patterson BM, McCarthy ML, Travison TG, Castillo RC. An analysis of outcomes of reconstruction or amputation after leg-threatening injuries. N Engl J Med. 2002 Dec 12;347(24):1924-31. doi: 10.1056/NEJMoa012604.
PubMed 12477942Castillo RC, MacKenzie EJ, Webb LX, Bosse MJ, Avery J; LEAP Study Group. Use and perceived need of physical therapy following severe lower-extremity trauma. Arch Phys Med Rehabil. 2005 Sep;86(9):1722-8. doi: 10.1016/j.apmr.2005.03.005.
PubMed 16181933O'Toole RV, Castillo RC, Pollak AN, MacKenzie EJ, Bosse MJ; LEAP Study Group. Determinants of patient satisfaction after severe lower-extremity injuries. J Bone Joint Surg Am. 2008 Jun;90(6):1206-11. doi: 10.2106/JBJS.G.00492.
PubMed 18519312Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.
PubMed 12873949Sherwood GD, McNeill JA, Starck PL, Disnard G. Changing acute pain management outcomes in surgical patients. AORN J. 2003 Feb;77(2):374, 377-80, 384-90 passim. doi: 10.1016/s0001-2092(06)61206-4.
PubMed 12619852Hsu JR, Mir H, Wally MK, Seymour RB; Orthopaedic Trauma Association Musculoskeletal Pain Task Force. Clinical Practice Guidelines for Pain Management in Acute Musculoskeletal Injury. J Orthop Trauma. 2019 May;33(5):e158-e182. doi: 10.1097/BOT.0000000000001430.
PubMed 30681429Oyler DR, Slade E, Slavova S, Matuszewski PE, Lei F, Herndon B, Johnson S, Moghadamian ES. Effect of a Multimodal Analgesic Protocol on Short-Term and Long-Term Opioid Use After Orthopaedic Trauma. J Orthop Trauma. 2022 Aug 1;36(8):326-331. doi: 10.1097/BOT.0000000000002346. Epub 2022 Jan 6.
PubMed 34999625Mir HR, Miller AN, Obremskey WT, Jahangir AA, Hsu JR. Confronting the Opioid Crisis: Practical Pain Management and Strategies: AOA 2018 Critical Issues Symposium. J Bone Joint Surg Am. 2019 Dec 4;101(23):e126. doi: 10.2106/JBJS.19.00285.
PubMed 31800430Castillo RC, Raja SN, Frey KP, Vallier HA, Tornetta P 3rd, Jaeblon T, Goff BJ, Gottschalk A, Scharfstein DO, O'Toole RV; METRC. Improving Pain Management and Long-Term Outcomes Following High-Energy Orthopaedic Trauma (Pain Study). J Orthop Trauma. 2017 Apr;31 Suppl 1:S71-S77. doi: 10.1097/BOT.0000000000000793.
PubMed 28323806Marquez-Lara A, Hutchinson ID, Nunez F Jr, Smith TL, Miller AN. Nonsteroidal Anti-Inflammatory Drugs and Bone-Healing: A Systematic Review of Research Quality. JBJS Rev. 2016 Mar 15;4(3):e4. doi: 10.2106/JBJS.RVW.O.00055.
PubMed 27500434Cepeda MS, Carr DB, Miranda N, Diaz A, Silva C, Morales O. Comparison of morphine, ketorolac, and their combination for postoperative pain: results from a large, randomized, double-blind trial. Anesthesiology. 2005 Dec;103(6):1225-32. doi: 10.1097/00000542-200512000-00018.
PubMed 16306736McDonald EL, Daniel JN, Rogero RG, Shakked RJ, Nicholson K, Pedowitz DI, Raikin SM, Bilolikar V, Winters BS. How Does Perioperative Ketorolac Affect Opioid Consumption and Pain Management After Ankle Fracture Surgery? Clin Orthop Relat Res. 2020 Jan;478(1):144-151. doi: 10.1097/CORR.0000000000000978.
PubMed 31567579
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Response to Trauma - Does Early Cytokine Modulation Improve Patient Outcome
- ClinicalTrials.gov ID
- NCT03671746
- Acronym / sponsor ID
- 43611
- Conditions
- Polytrauma
- Keywords
- Inflammatory cytokine, inflammation, trauma, opioid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Arun AnejaUniversity, hospital or other
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 14 Sep 2018 (actual)
- Results
- Posted 5 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 interleukin (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 a 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 an NSAID may lead to improved patient outcomes.
Over the last decade, clinicians have remained puzzled over the safety of NSAID administration after fracture in terms of bone union. In addition, given the current landscape for the 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Compare the effectiveness of a NSAID to placebo in acute trauma setting.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care without NSAID | Placebo comparator | Drug: Saline SolutionPolytrauma participants will receive standard of care in addition to saline solution according to standard Advanced Trauma Life Support (ATLS) and standard ICU routine medical care. |
| Standard of Care with NSAID | Experimental | Drug: KetorolacParticipants in the group will receive Ketorolac in addition to standard of care for the standard Advanced Trauma Life Support (ATLS) and standard ICU routine medical care. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients age 18 to 75
- New Injury Severity Score (NISS) > 9, with musculoskeletal injury requiring surgical treatment
Key exclusion criteria (10 listed)
- Patient age < 18 or > 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetorolacAlso: ToradolParticipants will receive Ketorolac at 15 mg IV every 6 hours for their first 5 days of hospitalization | Drug | Standard of Care with NSAID |
| Saline SolutionAlso: Normal SalineParticipants will receive 1 ml of saline solution IV every 6 hours for their first 5 days of hospitalization | Drug | Standard of Care without NSAID |
Primary outcome
Length of Hospital Stay
Time frame: Up to 30 days
Duration of the hospital stay will be calculated from electronic health record
11 secondary outcomes
Morphine Milligram Equivalents in House
Time frame: Hospital Day 0 (Enrollment), Day 1, Day 2, Day 3, Day 4, Day 5
Change in Patient Pain Scores
Time frame: Hospital Day 0 (Enrollment), Day 1, Day 2, Day 3, Day 4, Day 5
Change in Interleukin 1a
Time frame: Hospital Day 0 (Enrollment), Day 1, Day 2, Day 3, Day 4, Day 5
Change in Interleukin 1b
Time frame: Hospital Day 0 (Enrollment), Day 1, Day 2, Day 3, Day 4, Day 5
Change in Interleukin 6
Time frame: Hospital Day 0 (Enrollment), Day 1, Day 2, Day 3, Day 4, Day 5
Change in Interleukin 10
Time frame: Hospital Day 0 (Enrollment), Day 1, Day 2, Day 3, Day 4, Day 5
Change in Prostaglandin E-2
Time frame: Hospital Day 0 (Enrollment), Day 1, Day 2, Day 3, Day 4, Day 5
Post Traumatic Complications
Time frame: Up to 30 days
Mortality
Time frame: Up to 30 days
Change in Inpatient Subjective Pain Reports
Time frame: Hospital Day 0 (Enrollment), Day 1, Day 2, Day 3, Day 4, Day 5
Change in Outpatient Subjective Pain Reports
Time frame: up to 365 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18676205Braden JB, Fan MY, Edlund MJ, Martin BC, DeVries A, Sullivan MD. Trends in use of opioids by noncancer pain type 2000-2005 among Arkansas Medicaid and HealthCore enrollees: results from the TROUP study. J Pain. 2008 Nov;9(11):1026-35. doi: 10.1016/j.jpain.2008.06.002. Epub 2008 Jul 26.
- Background: PubMed 32584407Lawal OD, Gold J, Murthy A, Ruchi R, Bavry E, Hume AL, Lewkowitz AK, Brothers T, Wen X. Rate and Risk Factors Associated With Prolonged Opioid Use After Surgery: A Systematic Review and Meta-analysis. JAMA Netw Open. 2020 Jun 1;3(6):e207367. doi: 10.1001/jamanetworkopen.2020.7367.
- Background: PubMed 30063596Mohamadi A, Chan JJ, Lian J, Wright CL, Marin AM, Rodriguez EK, von Keudell A, Nazarian A. Risk Factors and Pooled Rate of Prolonged Opioid Use Following Trauma or Surgery: A Systematic Review and Meta-(Regression) Analysis. J Bone Joint Surg Am. 2018 Aug 1;100(15):1332-1340. doi: 10.2106/JBJS.17.01239.
- Background: PubMed 12477942Bosse MJ, MacKenzie EJ, Kellam JF, Burgess AR, Webb LX, Swiontkowski MF, Sanders RW, Jones AL, McAndrew MP, Patterson BM, McCarthy ML, Travison TG, Castillo RC. An analysis of outcomes of reconstruction or amputation after leg-threatening injuries. N Engl J Med. 2002 Dec 12;347(24):1924-31. doi: 10.1056/NEJMoa012604.
- Background: PubMed 16181933Castillo RC, MacKenzie EJ, Webb LX, Bosse MJ, Avery J; LEAP Study Group. Use and perceived need of physical therapy following severe lower-extremity trauma. Arch Phys Med Rehabil. 2005 Sep;86(9):1722-8. doi: 10.1016/j.apmr.2005.03.005.
- Background: PubMed 18519312O'Toole RV, Castillo RC, Pollak AN, MacKenzie EJ, Bosse MJ; LEAP Study Group. Determinants of patient satisfaction after severe lower-extremity injuries. J Bone Joint Surg Am. 2008 Jun;90(6):1206-11. doi: 10.2106/JBJS.G.00492.
- Background: PubMed 12873949Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.
- Background: PubMed 12619852Sherwood GD, McNeill JA, Starck PL, Disnard G. Changing acute pain management outcomes in surgical patients. AORN J. 2003 Feb;77(2):374, 377-80, 384-90 passim. doi: 10.1016/s0001-2092(06)61206-4.
- Background: PubMed 30681429Hsu JR, Mir H, Wally MK, Seymour RB; Orthopaedic Trauma Association Musculoskeletal Pain Task Force. Clinical Practice Guidelines for Pain Management in Acute Musculoskeletal Injury. J Orthop Trauma. 2019 May;33(5):e158-e182. doi: 10.1097/BOT.0000000000001430.
- Background: PubMed 34999625Oyler DR, Slade E, Slavova S, Matuszewski PE, Lei F, Herndon B, Johnson S, Moghadamian ES. Effect of a Multimodal Analgesic Protocol on Short-Term and Long-Term Opioid Use After Orthopaedic Trauma. J Orthop Trauma. 2022 Aug 1;36(8):326-331. doi: 10.1097/BOT.0000000000002346. Epub 2022 Jan 6.
- Background: PubMed 31800430Mir HR, Miller AN, Obremskey WT, Jahangir AA, Hsu JR. Confronting the Opioid Crisis: Practical Pain Management and Strategies: AOA 2018 Critical Issues Symposium. J Bone Joint Surg Am. 2019 Dec 4;101(23):e126. doi: 10.2106/JBJS.19.00285.
- Background: PubMed 28323806Castillo RC, Raja SN, Frey KP, Vallier HA, Tornetta P 3rd, Jaeblon T, Goff BJ, Gottschalk A, Scharfstein DO, O'Toole RV; METRC. Improving Pain Management and Long-Term Outcomes Following High-Energy Orthopaedic Trauma (Pain Study). J Orthop Trauma. 2017 Apr;31 Suppl 1:S71-S77. doi: 10.1097/BOT.0000000000000793.
- Pilot Study Results #1Link provided by the sponsor.
- Pilot Study Results #2Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arun Aneja, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ketorolac and Saline Solution in people with Polytrauma, run by Arun Aneja at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Hospital Stay (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03671746, which also lists 104 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.