Trial Outcomes & Findings for Inflammatory Markers in Trauma Patient Outcomes (NCT NCT03671746)

Results Overview

Duration of the hospital stay will be calculated from electronic health record

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

70 participants

Primary outcome timeframe

Up to 30 days

Results posted on

2025-06-05

Participant Flow

After obtaining institutional review board approval at a single Level I trauma center and clinical trial registration (ClinicalTrials.gov; NCT03671746), potential subjects were screened, recruited, and enrolled from February 2019 to October 2022. The types of locations in which participants were enrolled included the institution's emergency department, pre-operative holding area, or hospital unit.

No enrolled participants were excluded from the study before assignment to groups.

Participant milestones

Participant milestones
Measure	Standard of Care Without NSAID 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. Saline Solution: Participants will receive 1 ml of saline solution IV every 6 hours for their first 5 days of hospitalization	Standard of Care With NSAID Participants in the group will receive Ketorolac in addition to standard of care for the standard Advanced Trauma Life Support (ATLS) or ICU routine medical care. Ketorolac: Participants will receive Ketorolac at 15 mg IV every 6 hours for their first 5 days of hospitalization
Overall Study STARTED	35	35
Overall Study COMPLETED	35	35
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Inflammatory Markers in Trauma Patient Outcomes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard of Care Without NSAID n=35 Participants Polytrauma participants will receive standard of care in addition to saline solution according to standard ATLS and standard ICU routine medical care. Saline Solution: Participants will receive 1 ml of saline solution IV every 6 hours for their first 5 days of hospitalization	Standard of Care With NSAID n=35 Participants Participants in the group will receive Ketorolac in addition to standard of care for the standard ATLS or ICU routine medical care. Ketorolac: Participants will receive Ketorolac at 15 mg IV every 6 hours for their first 5 days of hospitalization	Total n=70 Participants Total of all reporting groups
Age, Continuous	40.0 years STANDARD_DEVIATION 16.2 • n=5 Participants	39.5 years STANDARD_DEVIATION 17.2 • n=7 Participants	39.8 years STANDARD_DEVIATION 16.6 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	21 Participants n=7 Participants	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants	33 Participants n=7 Participants	66 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Body Mass Index (BMI)	29.5 kg/m^2 STANDARD_DEVIATION 6.4 • n=5 Participants	28.2 kg/m^2 STANDARD_DEVIATION 7.3 • n=7 Participants	28.9 kg/m^2 STANDARD_DEVIATION 6.8 • n=5 Participants
New Injury Severity Score (NISS)	15.1 units on a scale STANDARD_DEVIATION 6.4 • n=5 Participants	14.0 units on a scale STANDARD_DEVIATION 5.2 • n=7 Participants	14.6 units on a scale STANDARD_DEVIATION 5.8 • n=5 Participants
Surgery Count	1.4 number of surgeries STANDARD_DEVIATION 0.7 • n=5 Participants	1.2 number of surgeries STANDARD_DEVIATION 0.6 • n=7 Participants	1.3 number of surgeries STANDARD_DEVIATION 0.6 • n=5 Participants

PRIMARY outcome

Timeframe: Up to 30 days

Duration of the hospital stay will be calculated from electronic health record

Outcome measures

Outcome measures
Measure	Standard of Care Without NSAID n=35 Participants Polytrauma participants will receive standard of care in addition to saline solution according to standard ATLS and standard ICU routine medical care. Saline Solution: Participants will receive 1 ml of saline solution IV every 6 hours for their first 5 days of hospitalization	Standard of Care With NSAID n=35 Participants Participants in the group will receive Ketorolac in addition to standard of care for the standard ATLS or ICU routine medical care. Ketorolac: Participants will receive Ketorolac at 15 mg IV every 6 hours for their first 5 days of hospitalization
Length of Hospital Stay	7 days Interval 3.0 to 10.0	8 days Interval 4.5 to 11.5

SECONDARY outcome

Timeframe: Hospital Day 0 (Enrollment), Day 1, Day 2, Day 3, Day 4, Day 5

The the morphine milligram equivalents (MME) will be recorded throughout the course of the hospital stay. These will be reported as daily totals.

Outcome measures

Outcome measures
Measure	Standard of Care Without NSAID n=35 Participants Polytrauma participants will receive standard of care in addition to saline solution according to standard ATLS and standard ICU routine medical care. Saline Solution: Participants will receive 1 ml of saline solution IV every 6 hours for their first 5 days of hospitalization	Standard of Care With NSAID n=35 Participants Participants in the group will receive Ketorolac in addition to standard of care for the standard ATLS or ICU routine medical care. Ketorolac: Participants will receive Ketorolac at 15 mg IV every 6 hours for their first 5 days of hospitalization
Morphine Milligram Equivalents in House Day 0 (Enrollment)	82.5 morphine milligram equivalents Interval 49.0 to 118.0	86 morphine milligram equivalents Interval 38.0 to 120.0
Morphine Milligram Equivalents in House Day 1	67.75 morphine milligram equivalents Interval 48.0 to 81.0	48.75 morphine milligram equivalents Interval 19.0 to 82.0
Morphine Milligram Equivalents in House Day 2	62 morphine milligram equivalents Interval 38.0 to 90.0	53 morphine milligram equivalents Interval 26.0 to 75.0
Morphine Milligram Equivalents in House Day 3	72 morphine milligram equivalents Interval 45.0 to 99.0	38.25 morphine milligram equivalents Interval 28.0 to 75.0
Morphine Milligram Equivalents in House Day 4	60 morphine milligram equivalents Interval 28.0 to 78.0	30 morphine milligram equivalents Interval 23.0 to 60.0
Morphine Milligram Equivalents in House Day 5	63.75 morphine milligram equivalents Interval 32.0 to 88.0	30 morphine milligram equivalents Interval 18.0 to 52.0

SECONDARY outcome

Timeframe: Hospital Day 0 (Enrollment), Day 1, Day 2, Day 3, Day 4, Day 5

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.

Outcome measures

Outcome measures
Measure	Standard of Care Without NSAID n=35 Participants Polytrauma participants will receive standard of care in addition to saline solution according to standard ATLS and standard ICU routine medical care. Saline Solution: Participants will receive 1 ml of saline solution IV every 6 hours for their first 5 days of hospitalization	Standard of Care With NSAID n=35 Participants Participants in the group will receive Ketorolac in addition to standard of care for the standard ATLS or ICU routine medical care. Ketorolac: Participants will receive Ketorolac at 15 mg IV every 6 hours for their first 5 days of hospitalization
Change in Patient Pain Scores Day 0 (Enrollment)	55.1 score on a scale Standard Deviation 27.5	68.2 score on a scale Standard Deviation 24.4
Change in Patient Pain Scores Day 1	52.2 score on a scale Standard Deviation 31.3	42.7 score on a scale Standard Deviation 25.6
Change in Patient Pain Scores Day 2	53.9 score on a scale Standard Deviation 26.5	47.4 score on a scale Standard Deviation 27.7
Change in Patient Pain Scores Day 3	54.1 score on a scale Standard Deviation 27.3	56.3 score on a scale Standard Deviation 26.0
Change in Patient Pain Scores Day 4	59.5 score on a scale Standard Deviation 26.9	43.3 score on a scale Standard Deviation 24.0
Change in Patient Pain Scores Day 5	59.2 score on a scale Standard Deviation 25.6	52.6 score on a scale Standard Deviation 21.9

SECONDARY outcome

Timeframe: Hospital Day 0 (Enrollment), Day 1, Day 2, Day 3, Day 4, Day 5

Population: The cytokine analysis was limited to only short-term inpatient data collected from the date of admission to inpatient Day 3. While research personnel attempted to recruit patients with anticipated hospital stays of at least five days, there was a notable decrease in hospitalized subjects past Day 3. To maintain study power and make meaningful conclusions, the authors decided to present findings analyzed during the first three hospital days.

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.

Outcome measures

Outcome measures
Measure	Standard of Care Without NSAID n=33 Participants Polytrauma participants will receive standard of care in addition to saline solution according to standard ATLS and standard ICU routine medical care. Saline Solution: Participants will receive 1 ml of saline solution IV every 6 hours for their first 5 days of hospitalization	Standard of Care With NSAID n=31 Participants Participants in the group will receive Ketorolac in addition to standard of care for the standard ATLS or ICU routine medical care. Ketorolac: Participants will receive Ketorolac at 15 mg IV every 6 hours for their first 5 days of hospitalization
Change in Interleukin 1a Day 0 (Enrollment)	115.1 fg/mL Interval 82.0 to 164.0	138.8 fg/mL Interval 65.0 to 177.0
Change in Interleukin 1a Day 1	112.7 fg/mL Interval 72.0 to 176.0	122.6 fg/mL Interval 79.0 to 169.0
Change in Interleukin 1a Day 2	119.3 fg/mL Interval 78.0 to 179.0	135.4 fg/mL Interval 60.0 to 207.0
Change in Interleukin 1a Day 3	104.2 fg/mL Interval 76.0 to 153.0	135.0 fg/mL Interval 45.0 to 189.0
Change in Interleukin 1a Day 4	150.2 fg/mL Interval 74.0 to 180.0	85.2 fg/mL Interval 23.0 to 203.0
Change in Interleukin 1a Day 5	101.9 fg/mL Interval 65.0 to 162.0	148.7 fg/mL Interval 77.0 to 176.0

SECONDARY outcome

Timeframe: Hospital Day 0 (Enrollment), Day 1, Day 2, Day 3, Day 4, Day 5

Population: The cytokine analysis was limited to only short-term inpatient data collected from the date of admission to inpatient Day 3. While research personnel attempted to recruit patients with anticipated hospital stays of at least five days, there was a notable decrease in hospitalized subjects past Day 3. To maintain study power and make meaningful conclusions, the authors decided to present findings analyzed during the first three hospital days.

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.

Outcome measures

Outcome measures
Measure	Standard of Care Without NSAID n=32 Participants Polytrauma participants will receive standard of care in addition to saline solution according to standard ATLS and standard ICU routine medical care. Saline Solution: Participants will receive 1 ml of saline solution IV every 6 hours for their first 5 days of hospitalization	Standard of Care With NSAID n=32 Participants Participants in the group will receive Ketorolac in addition to standard of care for the standard ATLS or ICU routine medical care. Ketorolac: Participants will receive Ketorolac at 15 mg IV every 6 hours for their first 5 days of hospitalization
Change in Interleukin 1b Day 0 (Enrollment)	0.119 pg/mL Interval 0.073 to 0.165	0.119 pg/mL Interval 0.085 to 0.187
Change in Interleukin 1b Day 1	0.095 pg/mL Interval 0.043 to 0.184	0.130 pg/mL Interval 0.07 to 0.199
Change in Interleukin 1b Day 2	0.084 pg/mL Interval 0.058 to 0.132	0.118 pg/mL Interval 0.08 to 0.23
Change in Interleukin 1b Day 3	0.091 pg/mL Interval 0.068 to 0.141	0.108 pg/mL Interval 0.072 to 0.276
Change in Interleukin 1b Day 4	0.064 pg/mL Interval 0.048 to 0.097	0.166 pg/mL Interval 0.091 to 0.216
Change in Interleukin 1b Day 5	0.056 pg/mL Interval 0.043 to 0.071	0.126 pg/mL Interval 0.081 to 0.184

SECONDARY outcome

Timeframe: Hospital Day 0 (Enrollment), Day 1, Day 2, Day 3, Day 4, Day 5

Population: The cytokine analysis was limited to only short-term inpatient data collected from the date of admission to inpatient Day 3. While research personnel attempted to recruit patients with anticipated hospital stays of at least five days, there was a notable decrease in hospitalized subjects past Day 3. To maintain study power and make meaningful conclusions, the authors decided to present findings analyzed during the first three hospital days.

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.

Outcome measures

Outcome measures
Measure	Standard of Care Without NSAID n=33 Participants Polytrauma participants will receive standard of care in addition to saline solution according to standard ATLS and standard ICU routine medical care. Saline Solution: Participants will receive 1 ml of saline solution IV every 6 hours for their first 5 days of hospitalization	Standard of Care With NSAID n=32 Participants Participants in the group will receive Ketorolac in addition to standard of care for the standard ATLS or ICU routine medical care. Ketorolac: Participants will receive Ketorolac at 15 mg IV every 6 hours for their first 5 days of hospitalization
Change in Interleukin 6 Day 0 (Enrollment)	21.5 pg/mL Interval 16.0 to 27.0	20.6 pg/mL Interval 13.0 to 25.0
Change in Interleukin 6 Day 1	21.2 pg/mL Interval 10.0 to 38.0	14.6 pg/mL Interval 8.0 to 34.0
Change in Interleukin 6 Day 2	16.3 pg/mL Interval 8.0 to 26.0	11.9 pg/mL Interval 6.0 to 18.0
Change in Interleukin 6 Day 3	12.9 pg/mL Interval 6.0 to 20.0	11.2 pg/mL Interval 6.0 to 27.0
Change in Interleukin 6 Day 4	7.9 pg/mL Interval 6.0 to 15.0	10.5 pg/mL Interval 7.0 to 23.0
Change in Interleukin 6 Day 5	10.5 pg/mL Interval 8.0 to 20.0	10.8 pg/mL Interval 5.0 to 26.0

SECONDARY outcome

Timeframe: Hospital Day 0 (Enrollment), Day 1, Day 2, Day 3, Day 4, Day 5

Population: The cytokine analysis was limited to only short-term inpatient data collected from the date of admission to inpatient Day 3. While research personnel attempted to recruit patients with anticipated hospital stays of at least five days, there was a notable decrease in hospitalized subjects past Day 3. To maintain study power and make meaningful conclusions, the authors decided to present findings analyzed during the first three hospital days.

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.

Outcome measures

Outcome measures
Measure	Standard of Care Without NSAID n=33 Participants Polytrauma participants will receive standard of care in addition to saline solution according to standard ATLS and standard ICU routine medical care. Saline Solution: Participants will receive 1 ml of saline solution IV every 6 hours for their first 5 days of hospitalization	Standard of Care With NSAID n=32 Participants Participants in the group will receive Ketorolac in addition to standard of care for the standard ATLS or ICU routine medical care. Ketorolac: Participants will receive Ketorolac at 15 mg IV every 6 hours for their first 5 days of hospitalization
Change in Interleukin 10 Day 2	0.57 pg/mL Interval 0.4 to 1.3	0.62 pg/mL Interval 0.4 to 1.1
Change in Interleukin 10 Day 0 (Enrollment)	1.10 pg/mL Interval 0.7 to 1.7	1.11 pg/mL Interval 0.8 to 2.3
Change in Interleukin 10 Day 1	0.90 pg/mL Interval 0.6 to 1.6	0.76 pg/mL Interval 0.5 to 1.1
Change in Interleukin 10 Day 3	0.65 pg/mL Interval 0.5 to 0.9	0.64 pg/mL Interval 0.5 to 1.5
Change in Interleukin 10 Day 4	0.49 pg/mL Interval 0.4 to 0.8	0.59 pg/mL Interval 0.5 to 0.9
Change in Interleukin 10 Day 5	0.72 pg/mL Interval 0.4 to 1.3	0.75 pg/mL Interval 0.4 to 1.0

SECONDARY outcome

Timeframe: Hospital Day 0 (Enrollment), Day 1, Day 2, Day 3, Day 4, Day 5

Population: The cytokine analysis was limited to only short-term inpatient data collected from the date of admission to inpatient Day 3. While research personnel attempted to recruit patients with anticipated hospital stays of at least five days, there was a notable decrease in hospitalized subjects past Day 3. To maintain study power and make meaningful conclusions, the authors decided to present findings analyzed during the first three hospital days.

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

Outcome measures

Outcome measures
Measure	Standard of Care Without NSAID n=26 Participants Polytrauma participants will receive standard of care in addition to saline solution according to standard ATLS and standard ICU routine medical care. Saline Solution: Participants will receive 1 ml of saline solution IV every 6 hours for their first 5 days of hospitalization	Standard of Care With NSAID n=28 Participants Participants in the group will receive Ketorolac in addition to standard of care for the standard ATLS or ICU routine medical care. Ketorolac: Participants will receive Ketorolac at 15 mg IV every 6 hours for their first 5 days of hospitalization
Change in Prostaglandin E-2 Day 4	347.6 pg/mL Interval 189.0 to 379.0	304.7 pg/mL Interval 237.0 to 430.0
Change in Prostaglandin E-2 Day 0 (Enrollment)	352.2 pg/mL Interval 161.0 to 673.0	448.3 pg/mL Interval 232.0 to 738.0
Change in Prostaglandin E-2 Day 1	477.0 pg/mL Interval 309.0 to 810.0	375.8 pg/mL Interval 292.0 to 587.0
Change in Prostaglandin E-2 Day 2	345.8 pg/mL Interval 178.0 to 563.0	356.6 pg/mL Interval 209.0 to 509.0
Change in Prostaglandin E-2 Day 3	319.8 pg/mL Interval 239.0 to 605.0	371.3 pg/mL Interval 251.0 to 515.0
Change in Prostaglandin E-2 Day 5	266.9 pg/mL Interval 209.0 to 475.0	322.3 pg/mL Interval 183.0 to 540.0

SECONDARY outcome

Timeframe: Up to 30 days

Population: Two participants were excluded from the secondary analysis, as blood samples were not able to be collected from these patients. Due to a transition in our institution's electronic medical record, one patient's chart could not be recovered, hence secondary clinical outcomes could not be collected for this patient (n=67).

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.

Outcome measures

Outcome measures
Measure	Standard of Care Without NSAID n=33 Participants Polytrauma participants will receive standard of care in addition to saline solution according to standard ATLS and standard ICU routine medical care. Saline Solution: Participants will receive 1 ml of saline solution IV every 6 hours for their first 5 days of hospitalization	Standard of Care With NSAID n=34 Participants Participants in the group will receive Ketorolac in addition to standard of care for the standard ATLS or ICU routine medical care. Ketorolac: Participants will receive Ketorolac at 15 mg IV every 6 hours for their first 5 days of hospitalization
Post Traumatic Complications Pulmonary Complications	4 Participants	3 Participants
Post Traumatic Complications Acute Kidney Injury (AKI)	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 30 days

Population: Two participants were excluded from the secondary analysis, as blood samples were not able to be collected from these patients (n=68). Due to a transition in our institution's electronic medical record, one patient's chart could not be recovered, hence secondary clinical outcomes could not be collected for this patient.

The Incidence of death related to the initial trauma/traumatic complications will be recorded for the first 30 days.

Outcome measures

Outcome measures
Measure	Standard of Care Without NSAID n=33 Participants Polytrauma participants will receive standard of care in addition to saline solution according to standard ATLS and standard ICU routine medical care. Saline Solution: Participants will receive 1 ml of saline solution IV every 6 hours for their first 5 days of hospitalization	Standard of Care With NSAID n=34 Participants Participants in the group will receive Ketorolac in addition to standard of care for the standard ATLS or ICU routine medical care. Ketorolac: Participants will receive Ketorolac at 15 mg IV every 6 hours for their first 5 days of hospitalization
Mortality	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Hospital Day 0 (Enrollment), Day 1, Day 2, Day 3, Day 4, Day 5

Population: Change in patient pain scores during the hospital stay was inadvertently entered twice (as outcomes #3: Change in Patient Pain Scores and #11: Change in Inpatient Subjective Pain Reports). These represent identical outcomes which was change in patient pain during the hospital stay. Please refer to outcome #3 for the corresponding data.

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.

Outcome measures

Outcome measures
Measure	Standard of Care Without NSAID n=35 Participants Polytrauma participants will receive standard of care in addition to saline solution according to standard ATLS and standard ICU routine medical care. Saline Solution: Participants will receive 1 ml of saline solution IV every 6 hours for their first 5 days of hospitalization	Standard of Care With NSAID n=35 Participants Participants in the group will receive Ketorolac in addition to standard of care for the standard ATLS or ICU routine medical care. Ketorolac: Participants will receive Ketorolac at 15 mg IV every 6 hours for their first 5 days of hospitalization
Change in Inpatient Subjective Pain Reports Day 0 (Enrollment)	55.1 score on a scale Standard Deviation 27.5	68.2 score on a scale Standard Deviation 24.4
Change in Inpatient Subjective Pain Reports Day 1	52.2 score on a scale Standard Deviation 31.3	42.7 score on a scale Standard Deviation 25.6
Change in Inpatient Subjective Pain Reports Day 4	59.5 score on a scale Standard Deviation 26.9	43.3 score on a scale Standard Deviation 24.0
Change in Inpatient Subjective Pain Reports Day 5	59.2 score on a scale Standard Deviation 25.6	52.6 score on a scale Standard Deviation 21.9
Change in Inpatient Subjective Pain Reports Day 2	53.9 score on a scale Standard Deviation 26.5	47.4 score on a scale Standard Deviation 27.7
Change in Inpatient Subjective Pain Reports Day 3	54.1 score on a scale Standard Deviation 27.3	56.3 score on a scale Standard Deviation 26.0

SECONDARY outcome

Timeframe: up to 365 days

Population: Only nine patients completed the required follow-up, resulting in insufficient data to conduct meaningful statistical analysis or draw clinically relevant conclusions.

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.

Outcome measures

Outcome measures
Measure	Standard of Care Without NSAID n=3 Participants Polytrauma participants will receive standard of care in addition to saline solution according to standard ATLS and standard ICU routine medical care. Saline Solution: Participants will receive 1 ml of saline solution IV every 6 hours for their first 5 days of hospitalization	Standard of Care With NSAID n=6 Participants Participants in the group will receive Ketorolac in addition to standard of care for the standard ATLS or ICU routine medical care. Ketorolac: Participants will receive Ketorolac at 15 mg IV every 6 hours for their first 5 days of hospitalization
Change in Outpatient Subjective Pain Reports	-22.7 units on a scale Interval -40.0 to -1.0	-16.7 units on a scale Interval -60.0 to -12.0

Adverse Events

Standard of Care Without NSAID

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Standard of Care With NSAID

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Standard of Care Without NSAID n=35 participants at risk Polytrauma participants will receive standard of care in addition to saline solution according to standard ATLS and standard ICU routine medical care. Saline Solution: Participants will receive 1 ml of saline solution IV every 6 hours for their first 5 days of hospitalization	Standard of Care With NSAID n=35 participants at risk Participants in the group will receive Ketorolac in addition to standard of care for the standard ATLS or ICU routine medical care. Ketorolac: Participants will receive Ketorolac at 15 mg IV every 6 hours for their first 5 days of hospitalization
Respiratory, thoracic and mediastinal disorders Pulmonary Complications	11.4% 4/35 • Number of events 4 • Up to 30 days	8.6% 3/35 • Number of events 3 • Up to 30 days
Renal and urinary disorders Acute Kidney Injury	5.7% 2/35 • Number of events 2 • Up to 30 days	0.00% 0/35 • Up to 30 days

Additional Information

Dr. Arun Aneja, MD, PhD

Massachusetts General Hospital

Phone: 617-726-6546

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place