Traumatic Injury
Conditions
Brief summary
Randomized, interventional trial of Emergency Department (ED) administration of DSUVIA (sufentanil) versus standard care pain management comparing pain treatment outcomes in injured patients with moderate to severe pain
Interventions
DRUGSufentanil 30 MCG Sublingual Tablet
30 microgram sublingual tablet administered using sublingual applicator
DRUGstandard care pain treatment
standard care pain treatment given in Emergency Department
Sponsors
United States Department of Defense
Frank Guyette
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Trauma activation (Level I, II or III) 2. Age 18-70 years inclusive 3. Need for pain treatment based upon NRS (0-100) clinical pain measurement ≥ 50 4. Estimated time in Emergency Department \> 30 minutes following informed consent
Exclusion criteria
1. Advanced airway management prior to 1st dose administration 2. Known allergy to opioids 3. Known prisoner 4. Known pregnancy 5. ED pain medication contraindicated 6. Significant respiratory depression 7. Known or suspected gastrointestinal obstruction, including paralytic ileus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verbally Administered Numeric Rating Scale (VNRS) | 30 minutes after administration | Verbally administered Numeric Rating Scale (VNRS) for clinical pain measurement (scale of 0-100, where 0 is having no pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Assessment (PGA) of Pain Control | every 30 minutes after administration until the time of ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration) | An assessment of the patient's pain, made by the patient themselves, made at 30 minute intervals up to 120 min after the intervention, or until discharge, or administration of rescue medication |
| Time-weighted Summed Pain Intensity Difference (SPID) @ 30, 60, 90, 120 Min | every 30 minutes after administration until ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration) | time-weighted Summed Pain Intensity Difference (SPID) is a statistical measure that calculates the cumulative pain reduction over a period of time by summing up the differences between baseline pain and current pain at various time points. The range for the SPID is 0-100 per time point, A score of 0 indicates no pain, a score of 100 indicating the worst pain intensity difference. Some patients did not participate in the SPID due to discharge or requiring rescue narcotic administration. |
| Number of Participants Who Needed Rescue Narcotic Doses | at 30 minutes following administration and during ED stay (up to 120 minutes) | Count of patients requiring additional pain medication after recieving the intervention (sufentanil) or the standard care control. |
| Patient Cognitive Function as Assessed by Six Item Screener (SIS) | at 30 minutes following administration | The Six Item Screener (SIS) is a simple assessment of cognitive impairment. It asks 6 questions, 3 based on recall and 3 based on orientation, each question is worth 1 point. The score can range between 0 and 6 correct answers. Higher numbers of correct answers indicated better outcomes (less cognitive impairment). Fewer patients were able to complete the SIS questionnaire then were enrolled in the study as some were discharged, received rescue medication or declined to participate prior to administration of the survey. |
| Healthcare Professional Global Assessment (HPGA) of Method of Pain Control | at 30 minutes following administration | Acceptability of pain treatment to health care providers based on a subjective assessment of the patients facial expressions, behavior, physical presentation and reported pain level. Nurses caring for the participant following treatment with the study drug were asked to characterize their patients pain relief as Poor, Fair, Good or Excellent. |
| Number of Participants With Hypoxia Needing Supplemental Oxygen | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) | The number of patients with an SpO2 less than 90 percent receiving supplemental oxygen |
| Number of Participants With Hypotension | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) | systolic blood pressure less than 90mmHg |
| Number of Participants With Nausea | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) | — |
| Verbally Administered Numeric Rating Scale (VNRS) | Every 30 min from 30 min post administration until the time of ED discharge or rescue narcotic administered and up to 120 minutes after administration, whichever comes first | Verbally administered Numeric Rating Scale (VNRS) for clinical pain measurement (scale of 0-100, where 0 is having no pain) |
| Number of Participants With Headache | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) | — |
| Number of Participants With Dizziness Requiring Treatment | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) | Dizziness requiring treatment |
| Number of Participants Who Had a 10 Point Reduction in VNRS Score @30 Min Intervals to 120min | Time to a 10 point reduction in VNRS following administration of study drug. Participants were followed to 120 min or discharge in 30 min intervals | The Number of participants that had a 10 point reduction in their VNRS @ 30min intervals to 120min |
| Number of Participants With Need for Bag Valve Mask Ventilation or Advanced Airway Management | From drug administration up to 120 min following administration | Need for advanced airway or bag valve mask ventilation |
| Richmond Agitation-Sedation Scale (RASS) | Assessed at 30 minutes after administration | The Richmond Agitation-Sedation Scale is scored from a -5 (unresponsive) to +4 (combative) with 0 being alert and calm. |
| Richmond Agitation-Sedation Scale (RASS) @ 60 Min | RASS @ 60 min | The Richmond Agitation-Sedation Scale is scored from a -5 (unresponsive) to +4 (combative) with 0 being alert and calm. Fewer patients were able to complete the SIS questionnaire then were enrolled in the study as some were discharged, received rescue medication or declined to participate prior to administration of the survey. |
| Richmond Agitation-Sedation Scale (RASS) @ 90 Min | RASS @ 90 minutes | The Richmond Agitation-Sedation Scale is scored from a -5 (unresponsive) to +4 (combative) with 0 being alert and calm.Fewer patients were able to complete the SIS questionnaire then were enrolled in the study as some were discharged, received rescue medication or declined to participate prior to administration of the survey. |
| Richmond Agitation-Sedation Scale (RASS) @ 120 Min | RASS @ 120 min | The Richmond Agitation-Sedation Scale is scored from a -5 (unresponsive) to +4 (combative) with 0 being alert and calm. Fewer patients were able to complete the SIS questionnaire then were enrolled in the study as some were discharged, received rescue medication or declined to participate prior to administration of the survey. |
| Number of Participants With Vomiting | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DSUVIA (Sufentanil) Subjects will receive a single dose of 30 micrograms DSUVIA (sufentanil) tablet utilizing a sublingual applicator
Sufentanil 30 MCG Sublingual Tablet: 30 microgram sublingual tablet administered using sublingual applicator | 76 |
| Standard Care Subjects will receive standard care pain management
standard care pain treatment: standard care pain treatment given in Emergency Department | 74 |
| Total | 150 |
Baseline characteristics
| Characteristic | Standard Care | Total | DSUVIA (Sufentanil) |
|---|---|---|---|
| Age, Continuous | 48 years STANDARD_DEVIATION 14 | 48 years STANDARD_DEVIATION 15 | 47 years STANDARD_DEVIATION 16 |
| Diastolic Blood Pressure | 86 mmHg STANDARD_DEVIATION 18 | 83 mmHg STANDARD_DEVIATION 21 | 79 mmHg STANDARD_DEVIATION 23 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 62 Participants | 123 Participants | 61 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 11 Participants | 25 Participants | 14 Participants |
| Heart Rate | 83 beats per minute STANDARD_DEVIATION 15 | 83 beats per minute STANDARD_DEVIATION 15 | 82 beats per minute STANDARD_DEVIATION 15 |
| Injury Severity Score | 5.5 units on a scale | 5 units on a scale | 5 units on a scale |
| Injury Type Blunt | 71 Participants | 144 Participants | 73 Participants |
| Injury Type Both | 1 Participants | 1 Participants | 0 Participants |
| Injury Type Penetrating | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 21 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 10 Participants | 7 Participants |
| Race (NIH/OMB) White | 55 Participants | 119 Participants | 64 Participants |
| Sex: Female, Male Female | 24 Participants | 48 Participants | 24 Participants |
| Sex: Female, Male Male | 50 Participants | 102 Participants | 52 Participants |
| Systolic Blood Pressure | 136 mmHg STANDARD_DEVIATION 23 | 136 mmHg STANDARD_DEVIATION 21 | 136 mmHg STANDARD_DEVIATION 20 |
| Total Glascow Coma Scale | 15 units on a scale STANDARD_DEVIATION 0 | 15 units on a scale STANDARD_DEVIATION 0 | 15 units on a scale STANDARD_DEVIATION 0 |
| Verbal Numerical Rating Scale @ 0 min | 81 units on a scale STANDARD_DEVIATION 14 | 81 units on a scale STANDARD_DEVIATION 15 | 81 units on a scale STANDARD_DEVIATION 15 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 76 | 0 / 74 |
| other Total, other adverse events | 5 / 76 | 4 / 74 |
| serious Total, serious adverse events | 7 / 76 | 6 / 74 |
Outcome results
Primary
Verbally Administered Numeric Rating Scale (VNRS)
Verbally administered Numeric Rating Scale (VNRS) for clinical pain measurement (scale of 0-100, where 0 is having no pain)
Time frame: 30 minutes after administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DSUVIA (Sufentanil) | Verbally Administered Numeric Rating Scale (VNRS) | 68 units on a scale | Standard Deviation 27 |
| Standard Care | Verbally Administered Numeric Rating Scale (VNRS) | 66 units on a scale | Standard Deviation 23 |
p-value: 0.5695% CI: [-6.19, 11.33]Mixed Models Analysis
Comparison: Adjusted for age, sex, respiratory rate and injury typep-value: 0.9295% CI: [-10.5, 9.48]Mixed Models Analysis
Secondary
Healthcare Professional Global Assessment (HPGA) of Method of Pain Control
Acceptability of pain treatment to health care providers based on a subjective assessment of the patients facial expressions, behavior, physical presentation and reported pain level. Nurses caring for the participant following treatment with the study drug were asked to characterize their patients pain relief as Poor, Fair, Good or Excellent.
Time frame: at 30 minutes following administration
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DSUVIA (Sufentanil) | Healthcare Professional Global Assessment (HPGA) of Method of Pain Control | Poor | 14 Participants |
| DSUVIA (Sufentanil) | Healthcare Professional Global Assessment (HPGA) of Method of Pain Control | Fair | 19 Participants |
| DSUVIA (Sufentanil) | Healthcare Professional Global Assessment (HPGA) of Method of Pain Control | Good | 23 Participants |
| DSUVIA (Sufentanil) | Healthcare Professional Global Assessment (HPGA) of Method of Pain Control | Excellent | 10 Participants |
| Standard Care | Healthcare Professional Global Assessment (HPGA) of Method of Pain Control | Excellent | 17 Participants |
| Standard Care | Healthcare Professional Global Assessment (HPGA) of Method of Pain Control | Poor | 5 Participants |
| Standard Care | Healthcare Professional Global Assessment (HPGA) of Method of Pain Control | Good | 28 Participants |
| Standard Care | Healthcare Professional Global Assessment (HPGA) of Method of Pain Control | Fair | 14 Participants |
Comparison: Healthcare Professional Global Assessment of method of pain control at 30 min.p-value: 0.00995% CI: [1.24, 4.46]Ordinal Polytomous Logisitic Regression
Comparison: Healthcare Professional Global Assessment of method of pain control at 30 min. adjusted for ISS and Racep-value: 0.0195% CI: [1.18, 4.29]Ordinal polytomous logistic regression
Secondary
Number of Participants Who Had a 10 Point Reduction in VNRS Score @30 Min Intervals to 120min
The Number of participants that had a 10 point reduction in their VNRS @ 30min intervals to 120min
Time frame: Time to a 10 point reduction in VNRS following administration of study drug. Participants were followed to 120 min or discharge in 30 min intervals
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DSUVIA (Sufentanil) | Number of Participants Who Had a 10 Point Reduction in VNRS Score @30 Min Intervals to 120min | Participants with a 10 point reduction @ 30 min | 28 Participants |
| DSUVIA (Sufentanil) | Number of Participants Who Had a 10 Point Reduction in VNRS Score @30 Min Intervals to 120min | Participants with a 10 point reduction @ 60 min | 41 Participants |
| DSUVIA (Sufentanil) | Number of Participants Who Had a 10 Point Reduction in VNRS Score @30 Min Intervals to 120min | Participants with a 10 point reduction @ 90 min | 42 Participants |
| DSUVIA (Sufentanil) | Number of Participants Who Had a 10 Point Reduction in VNRS Score @30 Min Intervals to 120min | Participants with a 10 point reduction @ 120 min | 42 Participants |
| Standard Care | Number of Participants Who Had a 10 Point Reduction in VNRS Score @30 Min Intervals to 120min | Participants with a 10 point reduction @ 120 min | 43 Participants |
| Standard Care | Number of Participants Who Had a 10 Point Reduction in VNRS Score @30 Min Intervals to 120min | Participants with a 10 point reduction @ 30 min | 36 Participants |
| Standard Care | Number of Participants Who Had a 10 Point Reduction in VNRS Score @30 Min Intervals to 120min | Participants with a 10 point reduction @ 90 min | 43 Participants |
| Standard Care | Number of Participants Who Had a 10 Point Reduction in VNRS Score @30 Min Intervals to 120min | Participants with a 10 point reduction @ 60 min | 41 Participants |
p-value: 0.995% CI: [0.69, 1.61]Regression, Cox
Comparison: Adjusted for Race and ISSp-value: 0.4895% CI: [0.75, 1.81]Regression, Cox
Secondary
Number of Participants Who Needed Rescue Narcotic Doses
Count of patients requiring additional pain medication after recieving the intervention (sufentanil) or the standard care control.
Time frame: at 30 minutes following administration and during ED stay (up to 120 minutes)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DSUVIA (Sufentanil) | Number of Participants Who Needed Rescue Narcotic Doses | 27 Participants |
| Standard Care | Number of Participants Who Needed Rescue Narcotic Doses | 29 Participants |
p-value: 0.6495% CI: [-1.96, 1.96]two sided test of proportion
Secondary
Number of Participants With Dizziness Requiring Treatment
Dizziness requiring treatment
Time frame: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DSUVIA (Sufentanil) | Number of Participants With Dizziness Requiring Treatment | 0 Participants |
| Standard Care | Number of Participants With Dizziness Requiring Treatment | 1 Participants |
p-value: >0.99Chi-squared
Secondary
Number of Participants With Headache
Time frame: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DSUVIA (Sufentanil) | Number of Participants With Headache | 1 Participants |
| Standard Care | Number of Participants With Headache | 2 Participants |
95% CI: [0.02, 5.12]
95% CI: [0.02, 4.56]
Secondary
Number of Participants With Hypotension
systolic blood pressure less than 90mmHg
Time frame: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DSUVIA (Sufentanil) | Number of Participants With Hypotension | 1 Participants |
| Standard Care | Number of Participants With Hypotension | 1 Participants |
95% CI: [0.04, 24.92]
95% CI: [0, 14.28]
Secondary
Number of Participants With Hypoxia Needing Supplemental Oxygen
The number of patients with an SpO2 less than 90 percent receiving supplemental oxygen
Time frame: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DSUVIA (Sufentanil) | Number of Participants With Hypoxia Needing Supplemental Oxygen | 4 Participants |
| Standard Care | Number of Participants With Hypoxia Needing Supplemental Oxygen | 4 Participants |
p-value: 0.9695% CI: [0.22, 4.26]Regression, Logistic
95% CI: [0.17, 5.04]
Secondary
Number of Participants With Nausea
Time frame: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DSUVIA (Sufentanil) | Number of Participants With Nausea | 5 Participants |
| Standard Care | Number of Participants With Nausea | 3 Participants |
95% CI: [0.39, 8.37]
95% CI: [0.39, 8.6]
Secondary
Number of Participants With Need for Bag Valve Mask Ventilation or Advanced Airway Management
Need for advanced airway or bag valve mask ventilation
Time frame: From drug administration up to 120 min following administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DSUVIA (Sufentanil) | Number of Participants With Need for Bag Valve Mask Ventilation or Advanced Airway Management | 0 Participants |
| Standard Care | Number of Participants With Need for Bag Valve Mask Ventilation or Advanced Airway Management | 0 Participants |
Secondary
Number of Participants With Vomiting
Time frame: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DSUVIA (Sufentanil) | Number of Participants With Vomiting | 3 Participants |
| Standard Care | Number of Participants With Vomiting | 0 Participants |
Secondary
Patient Cognitive Function as Assessed by Six Item Screener (SIS)
The Six Item Screener (SIS) is a simple assessment of cognitive impairment. It asks 6 questions, 3 based on recall and 3 based on orientation, each question is worth 1 point. The score can range between 0 and 6 correct answers. Higher numbers of correct answers indicated better outcomes (less cognitive impairment). Fewer patients were able to complete the SIS questionnaire then were enrolled in the study as some were discharged, received rescue medication or declined to participate prior to administration of the survey.
Time frame: at 30 minutes following administration
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DSUVIA (Sufentanil) | Patient Cognitive Function as Assessed by Six Item Screener (SIS) | 4 Correct | 5 Participants |
| DSUVIA (Sufentanil) | Patient Cognitive Function as Assessed by Six Item Screener (SIS) | 2 Correct | 4 Participants |
| DSUVIA (Sufentanil) | Patient Cognitive Function as Assessed by Six Item Screener (SIS) | 5 Correct | 7 Participants |
| DSUVIA (Sufentanil) | Patient Cognitive Function as Assessed by Six Item Screener (SIS) | 1 Correct | 8 Participants |
| DSUVIA (Sufentanil) | Patient Cognitive Function as Assessed by Six Item Screener (SIS) | 3 Correct | 4 Participants |
| DSUVIA (Sufentanil) | Patient Cognitive Function as Assessed by Six Item Screener (SIS) | 0 Correct | 18 Participants |
| DSUVIA (Sufentanil) | Patient Cognitive Function as Assessed by Six Item Screener (SIS) | 6 Correct | 20 Participants |
| Standard Care | Patient Cognitive Function as Assessed by Six Item Screener (SIS) | 0 Correct | 20 Participants |
| Standard Care | Patient Cognitive Function as Assessed by Six Item Screener (SIS) | 6 Correct | 22 Participants |
| Standard Care | Patient Cognitive Function as Assessed by Six Item Screener (SIS) | 5 Correct | 8 Participants |
| Standard Care | Patient Cognitive Function as Assessed by Six Item Screener (SIS) | 4 Correct | 4 Participants |
| Standard Care | Patient Cognitive Function as Assessed by Six Item Screener (SIS) | 3 Correct | 4 Participants |
| Standard Care | Patient Cognitive Function as Assessed by Six Item Screener (SIS) | 2 Correct | 3 Participants |
| Standard Care | Patient Cognitive Function as Assessed by Six Item Screener (SIS) | 1 Correct | 2 Participants |
p-value: 0.6195% CI: [-1.11, 0.66]General Additive Models
Comparison: 6 item screener adjusted analysisp-value: 0.5495% CI: [-1.23, 0.65]General Additive Model
Secondary
Patient Global Assessment (PGA) of Pain Control
An assessment of the patient's pain, made by the patient themselves, made at 30 minute intervals up to 120 min after the intervention, or until discharge, or administration of rescue medication
Time frame: every 30 minutes after administration until the time of ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration)
Population: Patient Global Assessment of Pain Control at 30 min
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| DSUVIA (Sufentanil) | Patient Global Assessment (PGA) of Pain Control | 30 min | Poor | 22 Participants |
| DSUVIA (Sufentanil) | Patient Global Assessment (PGA) of Pain Control | 30 min | Fair | 21 Participants |
| DSUVIA (Sufentanil) | Patient Global Assessment (PGA) of Pain Control | 30 min | Good | 17 Participants |
| DSUVIA (Sufentanil) | Patient Global Assessment (PGA) of Pain Control | 30 min | Excellent | 6 Participants |
| DSUVIA (Sufentanil) | Patient Global Assessment (PGA) of Pain Control | 60 min | Poor | 14 Participants |
| DSUVIA (Sufentanil) | Patient Global Assessment (PGA) of Pain Control | 60 min | Fair | 15 Participants |
| DSUVIA (Sufentanil) | Patient Global Assessment (PGA) of Pain Control | 60 min | Good | 15 Participants |
| DSUVIA (Sufentanil) | Patient Global Assessment (PGA) of Pain Control | 60 min | Excellent | 8 Participants |
| DSUVIA (Sufentanil) | Patient Global Assessment (PGA) of Pain Control | 90 min | Poor | 8 Participants |
| DSUVIA (Sufentanil) | Patient Global Assessment (PGA) of Pain Control | 90 min | Fair | 12 Participants |
| DSUVIA (Sufentanil) | Patient Global Assessment (PGA) of Pain Control | 90 min | Good | 12 Participants |
| DSUVIA (Sufentanil) | Patient Global Assessment (PGA) of Pain Control | 90 min | Excellent | 8 Participants |
| DSUVIA (Sufentanil) | Patient Global Assessment (PGA) of Pain Control | 120 min | Poor | 6 Participants |
| DSUVIA (Sufentanil) | Patient Global Assessment (PGA) of Pain Control | 120 min | Fair | 13 Participants |
| DSUVIA (Sufentanil) | Patient Global Assessment (PGA) of Pain Control | 120 min | Good | 9 Participants |
| DSUVIA (Sufentanil) | Patient Global Assessment (PGA) of Pain Control | 120 min | Excellent | 8 Participants |
| Standard Care | Patient Global Assessment (PGA) of Pain Control | 120 min | Excellent | 7 Participants |
| Standard Care | Patient Global Assessment (PGA) of Pain Control | 30 min | Poor | 12 Participants |
| Standard Care | Patient Global Assessment (PGA) of Pain Control | 90 min | Poor | 6 Participants |
| Standard Care | Patient Global Assessment (PGA) of Pain Control | 30 min | Fair | 14 Participants |
| Standard Care | Patient Global Assessment (PGA) of Pain Control | 120 min | Poor | 5 Participants |
| Standard Care | Patient Global Assessment (PGA) of Pain Control | 30 min | Good | 24 Participants |
| Standard Care | Patient Global Assessment (PGA) of Pain Control | 90 min | Fair | 11 Participants |
| Standard Care | Patient Global Assessment (PGA) of Pain Control | 30 min | Excellent | 13 Participants |
| Standard Care | Patient Global Assessment (PGA) of Pain Control | 120 min | Good | 8 Participants |
| Standard Care | Patient Global Assessment (PGA) of Pain Control | 60 min | Poor | 11 Participants |
| Standard Care | Patient Global Assessment (PGA) of Pain Control | 90 min | Good | 14 Participants |
| Standard Care | Patient Global Assessment (PGA) of Pain Control | 60 min | Fair | 14 Participants |
| Standard Care | Patient Global Assessment (PGA) of Pain Control | 120 min | Fair | 7 Participants |
| Standard Care | Patient Global Assessment (PGA) of Pain Control | 60 min | Good | 14 Participants |
| Standard Care | Patient Global Assessment (PGA) of Pain Control | 90 min | Excellent | 6 Participants |
| Standard Care | Patient Global Assessment (PGA) of Pain Control | 60 min | Excellent | 11 Participants |
p-value: 0.005Chi-squared
Secondary
Richmond Agitation-Sedation Scale (RASS)
The Richmond Agitation-Sedation Scale is scored from a -5 (unresponsive) to +4 (combative) with 0 being alert and calm.
Time frame: Assessed at 30 minutes after administration
Population: RASS @ 30 min
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) | RASS 4 @ 30 min | 0 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) | RASS 3 @ 30 min | 0 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) | RASS 2 @ 30 min | 1 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) | RASS 1 @ 30 min | 7 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) | RASS 0 @ 30 min | 46 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) | RASS -1 @ 30 min | 9 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) | RASS -2 @ 30 min | 2 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) | RASS -3 @ 30 min | 0 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) | RASS -4 @ 30 min | 0 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) | RASS -5 @ 30 min | 0 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) | RASS -3 @ 30 min | 1 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) | RASS 4 @ 30 min | 0 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) | RASS -1 @ 30 min | 8 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) | RASS 3 @ 30 min | 0 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) | RASS -5 @ 30 min | 0 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) | RASS 2 @ 30 min | 0 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) | RASS -2 @ 30 min | 0 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) | RASS 1 @ 30 min | 7 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) | RASS -4 @ 30 min | 0 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) | RASS 0 @ 30 min | 48 Participants |
p-value: 0.9995% CI: [-0.15, 0.15]Non parametric General Addative Model
Comparison: Adjustedp-value: 0.9695% CI: [-0.16, 0.15]Non Parametric General Additive Model
Secondary
Richmond Agitation-Sedation Scale (RASS) @ 120 Min
The Richmond Agitation-Sedation Scale is scored from a -5 (unresponsive) to +4 (combative) with 0 being alert and calm. Fewer patients were able to complete the SIS questionnaire then were enrolled in the study as some were discharged, received rescue medication or declined to participate prior to administration of the survey.
Time frame: RASS @ 120 min
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 120 Min | RASS 4 | 0 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 120 Min | RASS 3 | 0 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 120 Min | RASS 2 | 0 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 120 Min | RASS 1 | 2 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 120 Min | RASS 0 | 32 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 120 Min | RASS -1 | 2 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 120 Min | RASS -2 | 0 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 120 Min | RASS -3 | 0 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 120 Min | RASS -4 | 0 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 120 Min | RASS -5 | 0 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 120 Min | RASS -3 | 0 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 120 Min | RASS 4 | 0 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 120 Min | RASS -1 | 6 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 120 Min | RASS 3 | 0 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 120 Min | RASS -5 | 0 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 120 Min | RASS 2 | 0 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 120 Min | RASS -2 | 0 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 120 Min | RASS 1 | 1 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 120 Min | RASS -4 | 0 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 120 Min | RASS 0 | 20 Participants |
p-value: 0.7495% CI: [-0.25, 0.18]Non Parametric Generalized Additive Mode
Comparison: Adjustedp-value: 0.6395% CI: [-0.3, 0.18]Non Parametric Generalized Additive Mode
Secondary
Richmond Agitation-Sedation Scale (RASS) @ 60 Min
The Richmond Agitation-Sedation Scale is scored from a -5 (unresponsive) to +4 (combative) with 0 being alert and calm. Fewer patients were able to complete the SIS questionnaire then were enrolled in the study as some were discharged, received rescue medication or declined to participate prior to administration of the survey.
Time frame: RASS @ 60 min
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 60 Min | RASS 4 | 0 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 60 Min | RASS 3 | 0 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 60 Min | RASS 2 | 1 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 60 Min | RASS 1 | 3 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 60 Min | RASS 0 | 40 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 60 Min | RASS -1 | 5 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 60 Min | RASS -2 | 2 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 60 Min | RASS -3 | 0 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 60 Min | RASS -4 | 1 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 60 Min | RASS -5 | 0 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 60 Min | RASS -3 | 2 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 60 Min | RASS 4 | 0 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 60 Min | RASS -1 | 9 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 60 Min | RASS 3 | 0 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 60 Min | RASS -5 | 0 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 60 Min | RASS 2 | 1 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 60 Min | RASS -2 | 0 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 60 Min | RASS 1 | 4 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 60 Min | RASS -4 | 0 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 60 Min | RASS 0 | 34 Participants |
p-value: 0.8495% CI: [-0.17, 0.16]Non Parametric General Additive Model
Comparison: Adjustedp-value: 0.8495% CI: [-0.19, 0.16]Non Parametric Generalized Additive Mode
Secondary
Richmond Agitation-Sedation Scale (RASS) @ 90 Min
The Richmond Agitation-Sedation Scale is scored from a -5 (unresponsive) to +4 (combative) with 0 being alert and calm.Fewer patients were able to complete the SIS questionnaire then were enrolled in the study as some were discharged, received rescue medication or declined to participate prior to administration of the survey.
Time frame: RASS @ 90 minutes
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 90 Min | RASS 4 | 0 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 90 Min | RASS 3 | 0 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 90 Min | RASS 2 | 0 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 90 Min | RASS 1 | 2 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 90 Min | RASS 0 | 32 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 90 Min | RASS -1 | 4 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 90 Min | RASS -2 | 2 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 90 Min | RASS -3 | 0 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 90 Min | RASS -4 | 0 Participants |
| DSUVIA (Sufentanil) | Richmond Agitation-Sedation Scale (RASS) @ 90 Min | RASS -5 | 0 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 90 Min | RASS -3 | 0 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 90 Min | RASS 4 | 0 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 90 Min | RASS -1 | 6 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 90 Min | RASS 3 | 1 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 90 Min | RASS -5 | 0 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 90 Min | RASS 2 | 0 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 90 Min | RASS -2 | 1 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 90 Min | RASS 1 | 4 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 90 Min | RASS -4 | 0 Participants |
| Standard Care | Richmond Agitation-Sedation Scale (RASS) @ 90 Min | RASS 0 | 25 Participants |
p-value: 0.8195% CI: [-0.17, 0.22]Non Parametric Generalized Additive Mode
Comparison: Adjustedp-value: 0.9195% CI: [-0.2, 0.22]Non Parametric Generalized Additive Mode
Secondary
Time-weighted Summed Pain Intensity Difference (SPID) @ 30, 60, 90, 120 Min
time-weighted Summed Pain Intensity Difference (SPID) is a statistical measure that calculates the cumulative pain reduction over a period of time by summing up the differences between baseline pain and current pain at various time points. The range for the SPID is 0-100 per time point, A score of 0 indicates no pain, a score of 100 indicating the worst pain intensity difference. Some patients did not participate in the SPID due to discharge or requiring rescue narcotic administration.
Time frame: every 30 minutes after administration until ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DSUVIA (Sufentanil) | Time-weighted Summed Pain Intensity Difference (SPID) @ 30, 60, 90, 120 Min | 30 min | 6 units on a scale | Standard Deviation 10 |
| DSUVIA (Sufentanil) | Time-weighted Summed Pain Intensity Difference (SPID) @ 30, 60, 90, 120 Min | 60 min | 14 units on a scale | Standard Deviation 20 |
| DSUVIA (Sufentanil) | Time-weighted Summed Pain Intensity Difference (SPID) @ 30, 60, 90, 120 Min | 90 min | 22 units on a scale | Standard Deviation 31 |
| DSUVIA (Sufentanil) | Time-weighted Summed Pain Intensity Difference (SPID) @ 30, 60, 90, 120 Min | 120 min | 30 units on a scale | Standard Deviation 42 |
| Standard Care | Time-weighted Summed Pain Intensity Difference (SPID) @ 30, 60, 90, 120 Min | 120 min | 30 units on a scale | Standard Deviation 42 |
| Standard Care | Time-weighted Summed Pain Intensity Difference (SPID) @ 30, 60, 90, 120 Min | 30 min | 7 units on a scale | Standard Deviation 10 |
| Standard Care | Time-weighted Summed Pain Intensity Difference (SPID) @ 30, 60, 90, 120 Min | 90 min | 22 units on a scale | Standard Deviation 30 |
| Standard Care | Time-weighted Summed Pain Intensity Difference (SPID) @ 30, 60, 90, 120 Min | 60 min | 14 units on a scale | Standard Deviation 20 |
Comparison: SPID 30~last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed valuep-value: 0.3995% CI: [-4.77, 1.89]General Addative Model
Comparison: SPID 30, Adjusted Analysis~last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed valuep-value: 0.2995% CI: [-1.5, 4.95]General Additive Model
Comparison: SPID @ 60min last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed valuep-value: 0.9895% CI: [-6.63, 6.47]Generalized Additive Model
Comparison: SPID 60 Adjusted~Last observed carried forward to address missingnessp-value: 0.8595% CI: [-5.76, 6.98]Generalized Additive Model
Comparison: SPID @ 90 mn last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed valuep-value: 0.895% CI: [-8.75, 11.28]Generalized Additive Model
Comparison: SPID 90 min Adjusted~last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed valuep-value: 0.9295% CI: [-10.2, 9.92]Generalized Additive Model
Comparison: SPID @ 120 min last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed valuep-value: 0.6495% CI: [-10.45, 16.9]Generalized Additive Model
Comparison: SPID 120 Adjusted~last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed valuep-value: 0.7595% CI: [-15.6, 11.3]Generalized Additive Model
Secondary
Verbally Administered Numeric Rating Scale (VNRS)
Verbally administered Numeric Rating Scale (VNRS) for clinical pain measurement (scale of 0-100, where 0 is having no pain)
Time frame: Every 30 min from 30 min post administration until the time of ED discharge or rescue narcotic administered and up to 120 minutes after administration, whichever comes first
Population: The number of patients analyzed at subsequent time points decreases as patients received rescue medications or left the Emergency Department (for admission, operative intervention, or discharge) prior to the 2 hr follow up period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DSUVIA (Sufentanil) | Verbally Administered Numeric Rating Scale (VNRS) | 30 minutes | 68 units on a scale | Standard Deviation 27 |
| DSUVIA (Sufentanil) | Verbally Administered Numeric Rating Scale (VNRS) | 60 minutes | 59 units on a scale | Standard Deviation 29 |
| DSUVIA (Sufentanil) | Verbally Administered Numeric Rating Scale (VNRS) | 90 minutes | 53 units on a scale | Standard Deviation 29 |
| DSUVIA (Sufentanil) | Verbally Administered Numeric Rating Scale (VNRS) | 120 minutes | 53 units on a scale | Standard Deviation 30 |
| Standard Care | Verbally Administered Numeric Rating Scale (VNRS) | 120 minutes | 62 units on a scale | Standard Deviation 28 |
| Standard Care | Verbally Administered Numeric Rating Scale (VNRS) | 30 minutes | 66 units on a scale | Standard Deviation 23 |
| Standard Care | Verbally Administered Numeric Rating Scale (VNRS) | 90 minutes | 64 units on a scale | Standard Deviation 27 |
| Standard Care | Verbally Administered Numeric Rating Scale (VNRS) | 60 minutes | 66 units on a scale | Standard Deviation 27 |
Comparison: VNRS @ 60minp-value: 0.1895% CI: [-17.66, 3.37]Mixed Models Analysis
Comparison: VNRS @ 60 min Adjusted for sex and injury typep-value: 0.6395% CI: [-9.3, 15.1]Mixed Models Analysis
Comparison: VNRS @ 90 minp-value: 0.0895% CI: [-22.39, 1.21]Mixed Models Analysis
Comparison: VNRS @90min adjustedp-value: 0.2895% CI: [-6.13, 20.8]Mixed Models Analysis
Comparison: VNRS @ 120 minp-value: 0.1895% CI: [-23.6, 4.56]Mixed Models Analysis
Comparison: VNRS @ 120min adjusted for sex, HR, RR, and injury typep-value: 0.595% CI: [-20.7, 10.2]Mixed Models Analysis