Trial Outcomes & Findings for DSUVIA Early Evaluation of Pain Trial (NCT NCT05288348)

NCT ID: NCT05288348

Last Updated: 2025-04-30

Results Overview

Verbally administered Numeric Rating Scale (VNRS) for clinical pain measurement (scale of 0-100, where 0 is having no pain)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 150 participants
• Primary outcome timeframe: 30 minutes after administration
• Results posted on: 2025-04-30

Participant Flow

Participant milestones

Measure	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	Standard Care Subjects will receive standard care pain management standard care pain treatment: standard care pain treatment given in Emergency Department
Overall Study STARTED	76	74
Overall Study COMPLETED	76	74
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

DSUVIA Early Evaluation of Pain Trial

Baseline characteristics by cohort

Measure	DSUVIA (Sufentanil) n=76 Participants 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	Standard Care n=74 Participants Subjects will receive standard care pain management standard care pain treatment: standard care pain treatment given in Emergency Department	Total n=150 Participants Total of all reporting groups
Age, Continuous	47 years STANDARD_DEVIATION 16 • n=5 Participants	48 years STANDARD_DEVIATION 14 • n=7 Participants	48 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants	50 Participants n=7 Participants	102 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	61 Participants n=5 Participants	62 Participants n=7 Participants	123 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants	11 Participants n=7 Participants	25 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	5 Participants n=5 Participants	16 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) White	64 Participants n=5 Participants	55 Participants n=7 Participants	119 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	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Total Glascow Coma Scale	15 units on a scale STANDARD_DEVIATION 0 • n=5 Participants	15 units on a scale STANDARD_DEVIATION 0 • n=7 Participants	15 units on a scale STANDARD_DEVIATION 0 • n=5 Participants
Injury Severity Score	5 units on a scale n=5 Participants	5.5 units on a scale n=7 Participants	5 units on a scale n=5 Participants
Injury Type Blunt	73 Participants n=5 Participants	71 Participants n=7 Participants	144 Participants n=5 Participants
Injury Type Penetrating	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Injury Type Both	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Verbal Numerical Rating Scale @ 0 min	81 units on a scale STANDARD_DEVIATION 15 • n=5 Participants	81 units on a scale STANDARD_DEVIATION 14 • n=7 Participants	81 units on a scale STANDARD_DEVIATION 15 • n=5 Participants
Systolic Blood Pressure	136 mmHg STANDARD_DEVIATION 20 • n=5 Participants	136 mmHg STANDARD_DEVIATION 23 • n=7 Participants	136 mmHg STANDARD_DEVIATION 21 • n=5 Participants
Diastolic Blood Pressure	79 mmHg STANDARD_DEVIATION 23 • n=5 Participants	86 mmHg STANDARD_DEVIATION 18 • n=7 Participants	83 mmHg STANDARD_DEVIATION 21 • n=5 Participants
Heart Rate	82 beats per minute STANDARD_DEVIATION 15 • n=5 Participants	83 beats per minute STANDARD_DEVIATION 15 • n=7 Participants	83 beats per minute STANDARD_DEVIATION 15 • n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes after administration

Verbally administered Numeric Rating Scale (VNRS) for clinical pain measurement (scale of 0-100, where 0 is having no pain)

Outcome measures

Measure	DSUVIA (Sufentanil) n=76 Participants 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	Standard Care n=74 Participants Subjects will receive standard care pain management standard care pain treatment: standard care pain treatment given in Emergency Department
Verbally Administered Numeric Rating Scale (VNRS)	68 units on a scale Standard Deviation 27	66 units on a scale Standard Deviation 23

SECONDARY outcome

Timeframe: 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.

Verbally administered Numeric Rating Scale (VNRS) for clinical pain measurement (scale of 0-100, where 0 is having no pain)

Outcome measures

Measure	DSUVIA (Sufentanil) n=76 Participants 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	Standard Care n=74 Participants Subjects will receive standard care pain management standard care pain treatment: standard care pain treatment given in Emergency Department
Verbally Administered Numeric Rating Scale (VNRS) 30 minutes	68 units on a scale Standard Deviation 27	66 units on a scale Standard Deviation 23
Verbally Administered Numeric Rating Scale (VNRS) 60 minutes	59 units on a scale Standard Deviation 29	66 units on a scale Standard Deviation 27
Verbally Administered Numeric Rating Scale (VNRS) 90 minutes	53 units on a scale Standard Deviation 29	64 units on a scale Standard Deviation 27
Verbally Administered Numeric Rating Scale (VNRS) 120 minutes	53 units on a scale Standard Deviation 30	62 units on a scale Standard Deviation 28

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Measure	DSUVIA (Sufentanil) n=66 Participants 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	Standard Care n=63 Participants Subjects will receive standard care pain management standard care pain treatment: standard care pain treatment given in Emergency Department
Patient Global Assessment (PGA) of Pain Control 90 min · Excellent	8 Participants	6 Participants
Patient Global Assessment (PGA) of Pain Control 30 min · Poor	22 Participants	12 Participants
Patient Global Assessment (PGA) of Pain Control 30 min · Fair	21 Participants	14 Participants
Patient Global Assessment (PGA) of Pain Control 30 min · Good	17 Participants	24 Participants
Patient Global Assessment (PGA) of Pain Control 30 min · Excellent	6 Participants	13 Participants
Patient Global Assessment (PGA) of Pain Control 60 min · Poor	14 Participants	11 Participants
Patient Global Assessment (PGA) of Pain Control 60 min · Fair	15 Participants	14 Participants
Patient Global Assessment (PGA) of Pain Control 60 min · Good	15 Participants	14 Participants
Patient Global Assessment (PGA) of Pain Control 60 min · Excellent	8 Participants	11 Participants
Patient Global Assessment (PGA) of Pain Control 90 min · Poor	8 Participants	6 Participants
Patient Global Assessment (PGA) of Pain Control 90 min · Fair	12 Participants	11 Participants
Patient Global Assessment (PGA) of Pain Control 90 min · Good	12 Participants	14 Participants
Patient Global Assessment (PGA) of Pain Control 120 min · Poor	6 Participants	5 Participants
Patient Global Assessment (PGA) of Pain Control 120 min · Fair	13 Participants	7 Participants
Patient Global Assessment (PGA) of Pain Control 120 min · Good	9 Participants	8 Participants
Patient Global Assessment (PGA) of Pain Control 120 min · Excellent	8 Participants	7 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	DSUVIA (Sufentanil) n=69 Participants 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	Standard Care n=72 Participants Subjects will receive standard care pain management standard care pain treatment: standard care pain treatment given in Emergency Department
Time-weighted Summed Pain Intensity Difference (SPID) @ 30, 60, 90, 120 Min 30 min	6 units on a scale Standard Deviation 10	7 units on a scale Standard Deviation 10
Time-weighted Summed Pain Intensity Difference (SPID) @ 30, 60, 90, 120 Min 60 min	14 units on a scale Standard Deviation 20	14 units on a scale Standard Deviation 20
Time-weighted Summed Pain Intensity Difference (SPID) @ 30, 60, 90, 120 Min 90 min	22 units on a scale Standard Deviation 31	22 units on a scale Standard Deviation 30
Time-weighted Summed Pain Intensity Difference (SPID) @ 30, 60, 90, 120 Min 120 min	30 units on a scale Standard Deviation 42	30 units on a scale Standard Deviation 42

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	DSUVIA (Sufentanil) n=76 Participants 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	Standard Care n=74 Participants Subjects will receive standard care pain management standard care pain treatment: standard care pain treatment given in Emergency Department
Number of Participants Who Needed Rescue Narcotic Doses	27 Participants	29 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	DSUVIA (Sufentanil) n=66 Participants 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	Standard Care n=63 Participants Subjects will receive standard care pain management standard care pain treatment: standard care pain treatment given in Emergency Department
Patient Cognitive Function as Assessed by Six Item Screener (SIS) 6 Correct	20 Participants	22 Participants
Patient Cognitive Function as Assessed by Six Item Screener (SIS) 5 Correct	7 Participants	8 Participants
Patient Cognitive Function as Assessed by Six Item Screener (SIS) 4 Correct	5 Participants	4 Participants
Patient Cognitive Function as Assessed by Six Item Screener (SIS) 3 Correct	4 Participants	4 Participants
Patient Cognitive Function as Assessed by Six Item Screener (SIS) 2 Correct	4 Participants	3 Participants
Patient Cognitive Function as Assessed by Six Item Screener (SIS) 1 Correct	8 Participants	2 Participants
Patient Cognitive Function as Assessed by Six Item Screener (SIS) 0 Correct	18 Participants	20 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	DSUVIA (Sufentanil) n=66 Participants 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	Standard Care n=64 Participants Subjects will receive standard care pain management standard care pain treatment: standard care pain treatment given in Emergency Department
Healthcare Professional Global Assessment (HPGA) of Method of Pain Control Poor	14 Participants	5 Participants
Healthcare Professional Global Assessment (HPGA) of Method of Pain Control Fair	19 Participants	14 Participants
Healthcare Professional Global Assessment (HPGA) of Method of Pain Control Good	23 Participants	28 Participants
Healthcare Professional Global Assessment (HPGA) of Method of Pain Control Excellent	10 Participants	17 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	DSUVIA (Sufentanil) n=76 Participants 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	Standard Care n=74 Participants Subjects will receive standard care pain management standard care pain treatment: standard care pain treatment given in Emergency Department
Number of Participants With Hypoxia Needing Supplemental Oxygen	4 Participants	4 Participants

SECONDARY outcome

Timeframe: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)

systolic blood pressure less than 90mmHg

Outcome measures

Measure	DSUVIA (Sufentanil) n=76 Participants 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	Standard Care n=74 Participants Subjects will receive standard care pain management standard care pain treatment: standard care pain treatment given in Emergency Department
Number of Participants With Hypotension	1 Participants	1 Participants

SECONDARY outcome

Timeframe: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)

Outcome measures

Measure	DSUVIA (Sufentanil) n=76 Participants 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	Standard Care n=74 Participants Subjects will receive standard care pain management standard care pain treatment: standard care pain treatment given in Emergency Department
Number of Participants With Nausea	5 Participants	3 Participants

SECONDARY outcome

Timeframe: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)

Outcome measures

Measure	DSUVIA (Sufentanil) n=76 Participants 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	Standard Care n=74 Participants Subjects will receive standard care pain management standard care pain treatment: standard care pain treatment given in Emergency Department
Number of Participants With Vomiting	3 Participants	0 Participants

SECONDARY outcome

Timeframe: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)

Outcome measures

Measure	DSUVIA (Sufentanil) n=76 Participants 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	Standard Care n=74 Participants Subjects will receive standard care pain management standard care pain treatment: standard care pain treatment given in Emergency Department
Number of Participants With Headache	1 Participants	2 Participants

SECONDARY outcome

Timeframe: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)

Dizziness requiring treatment

Outcome measures

Measure	DSUVIA (Sufentanil) n=76 Participants 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	Standard Care n=74 Participants Subjects will receive standard care pain management standard care pain treatment: standard care pain treatment given in Emergency Department
Number of Participants With Dizziness Requiring Treatment	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	DSUVIA (Sufentanil) n=76 Participants 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	Standard Care n=74 Participants Subjects will receive standard care pain management standard care pain treatment: standard care pain treatment given in Emergency Department
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	36 Participants
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	41 Participants
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	43 Participants
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	43 Participants

SECONDARY outcome

Timeframe: From drug administration up to 120 min following administration

Need for advanced airway or bag valve mask ventilation

Outcome measures

Measure	DSUVIA (Sufentanil) n=76 Participants 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	Standard Care n=74 Participants Subjects will receive standard care pain management standard care pain treatment: standard care pain treatment given in Emergency Department
Number of Participants With Need for Bag Valve Mask Ventilation or Advanced Airway Management	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Assessed at 30 minutes after administration

Population: RASS @ 30 min

The Richmond Agitation-Sedation Scale is scored from a -5 (unresponsive) to +4 (combative) with 0 being alert and calm.

Outcome measures

Measure	DSUVIA (Sufentanil) n=65 Participants 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	Standard Care n=64 Participants Subjects will receive standard care pain management standard care pain treatment: standard care pain treatment given in Emergency Department
Richmond Agitation-Sedation Scale (RASS) RASS 4 @ 30 min	0 Participants	0 Participants
Richmond Agitation-Sedation Scale (RASS) RASS 3 @ 30 min	0 Participants	0 Participants
Richmond Agitation-Sedation Scale (RASS) RASS 2 @ 30 min	1 Participants	0 Participants
Richmond Agitation-Sedation Scale (RASS) RASS 1 @ 30 min	7 Participants	7 Participants
Richmond Agitation-Sedation Scale (RASS) RASS 0 @ 30 min	46 Participants	48 Participants
Richmond Agitation-Sedation Scale (RASS) RASS -1 @ 30 min	9 Participants	8 Participants
Richmond Agitation-Sedation Scale (RASS) RASS -2 @ 30 min	2 Participants	0 Participants
Richmond Agitation-Sedation Scale (RASS) RASS -3 @ 30 min	0 Participants	1 Participants
Richmond Agitation-Sedation Scale (RASS) RASS -4 @ 30 min	0 Participants	0 Participants
Richmond Agitation-Sedation Scale (RASS) RASS -5 @ 30 min	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	DSUVIA (Sufentanil) n=52 Participants 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	Standard Care n=50 Participants Subjects will receive standard care pain management standard care pain treatment: standard care pain treatment given in Emergency Department
Richmond Agitation-Sedation Scale (RASS) @ 60 Min RASS 0	40 Participants	34 Participants
Richmond Agitation-Sedation Scale (RASS) @ 60 Min RASS -1	5 Participants	9 Participants
Richmond Agitation-Sedation Scale (RASS) @ 60 Min RASS 4	0 Participants	0 Participants
Richmond Agitation-Sedation Scale (RASS) @ 60 Min RASS 3	0 Participants	0 Participants
Richmond Agitation-Sedation Scale (RASS) @ 60 Min RASS 2	1 Participants	1 Participants
Richmond Agitation-Sedation Scale (RASS) @ 60 Min RASS 1	3 Participants	4 Participants
Richmond Agitation-Sedation Scale (RASS) @ 60 Min RASS -2	2 Participants	0 Participants
Richmond Agitation-Sedation Scale (RASS) @ 60 Min RASS -3	0 Participants	2 Participants
Richmond Agitation-Sedation Scale (RASS) @ 60 Min RASS -4	1 Participants	0 Participants
Richmond Agitation-Sedation Scale (RASS) @ 60 Min RASS -5	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	DSUVIA (Sufentanil) n=40 Participants 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	Standard Care n=37 Participants Subjects will receive standard care pain management standard care pain treatment: standard care pain treatment given in Emergency Department
Richmond Agitation-Sedation Scale (RASS) @ 90 Min RASS -2	2 Participants	1 Participants
Richmond Agitation-Sedation Scale (RASS) @ 90 Min RASS 4	0 Participants	0 Participants
Richmond Agitation-Sedation Scale (RASS) @ 90 Min RASS 3	0 Participants	1 Participants
Richmond Agitation-Sedation Scale (RASS) @ 90 Min RASS 2	0 Participants	0 Participants
Richmond Agitation-Sedation Scale (RASS) @ 90 Min RASS 1	2 Participants	4 Participants
Richmond Agitation-Sedation Scale (RASS) @ 90 Min RASS 0	32 Participants	25 Participants
Richmond Agitation-Sedation Scale (RASS) @ 90 Min RASS -1	4 Participants	6 Participants
Richmond Agitation-Sedation Scale (RASS) @ 90 Min RASS -3	0 Participants	0 Participants
Richmond Agitation-Sedation Scale (RASS) @ 90 Min RASS -4	0 Participants	0 Participants
Richmond Agitation-Sedation Scale (RASS) @ 90 Min RASS -5	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	DSUVIA (Sufentanil) n=36 Participants 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	Standard Care n=27 Participants Subjects will receive standard care pain management standard care pain treatment: standard care pain treatment given in Emergency Department
Richmond Agitation-Sedation Scale (RASS) @ 120 Min RASS 1	2 Participants	1 Participants
Richmond Agitation-Sedation Scale (RASS) @ 120 Min RASS 4	0 Participants	0 Participants
Richmond Agitation-Sedation Scale (RASS) @ 120 Min RASS 3	0 Participants	0 Participants
Richmond Agitation-Sedation Scale (RASS) @ 120 Min RASS 2	0 Participants	0 Participants
Richmond Agitation-Sedation Scale (RASS) @ 120 Min RASS 0	32 Participants	20 Participants
Richmond Agitation-Sedation Scale (RASS) @ 120 Min RASS -1	2 Participants	6 Participants
Richmond Agitation-Sedation Scale (RASS) @ 120 Min RASS -2	0 Participants	0 Participants
Richmond Agitation-Sedation Scale (RASS) @ 120 Min RASS -3	0 Participants	0 Participants
Richmond Agitation-Sedation Scale (RASS) @ 120 Min RASS -4	0 Participants	0 Participants
Richmond Agitation-Sedation Scale (RASS) @ 120 Min RASS -5	0 Participants	0 Participants

Adverse Events

DSUVIA (Sufentanil)

Serious events: 7 serious events

Other events: 5 other events

Deaths: 0 deaths

Standard Care

Serious events: 6 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	DSUVIA (Sufentanil) n=76 participants at risk 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	Standard Care n=74 participants at risk Subjects will receive standard care pain management standard care pain treatment: standard care pain treatment given in Emergency Department
Respiratory, thoracic and mediastinal disorders Hypoxia	5.3% 4/76 • Number of events 4 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.	5.4% 4/74 • Number of events 4 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.
General disorders Hypotension	1.3% 1/76 • Number of events 1 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.	1.4% 1/74 • Number of events 1 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.
Gastrointestinal disorders Nausea	1.3% 1/76 • Number of events 1 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.	1.4% 1/74 • Number of events 1 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.
Gastrointestinal disorders Vomiting	1.3% 1/76 • Number of events 1 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.	0.00% 0/74 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.
Nervous system disorders Headache	0.00% 0/76 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.	0.00% 0/74 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.
Nervous system disorders Dizziness	0.00% 0/76 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.	1.4% 1/74 • Number of events 1 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.
Respiratory, thoracic and mediastinal disorders Need for an advanced airway	0.00% 0/76 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.	0.00% 0/74 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.
Respiratory, thoracic and mediastinal disorders Need for Supplemental Oxygen to maintain SpO2 >90%	0.00% 0/76 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.	0.00% 0/74 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.

Other adverse events

Measure	DSUVIA (Sufentanil) n=76 participants at risk 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	Standard Care n=74 participants at risk Subjects will receive standard care pain management standard care pain treatment: standard care pain treatment given in Emergency Department
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/76 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.	0.00% 0/74 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.
General disorders Hypotension	0.00% 0/76 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.	0.00% 0/74 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.
Gastrointestinal disorders Nausea	5.3% 4/76 • Number of events 4 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.	2.7% 2/74 • Number of events 2 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.
Gastrointestinal disorders Vomiting	2.6% 2/76 • Number of events 2 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.	0.00% 0/74 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.
Nervous system disorders Headache	1.3% 1/76 • Number of events 1 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.	2.7% 2/74 • Number of events 2 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.
Nervous system disorders Dizziness	0.00% 0/76 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.	1.4% 1/74 • Number of events 1 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.
Respiratory, thoracic and mediastinal disorders Need for supplemental oxygen	0.00% 0/76 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.	0.00% 0/74 • Adverse events were collected up to 120 minutes after administration of the study drug Adverse events included hypoxia (SpO2 \<90%) requiring supplemental oxygen, hypotension (SBP\<90mmHg), need for bag mask ventilation or placement of an advanced airway. Episodes of nausea, vomiting, headache or dizziness requiring treatment also counted as an adverse event. Research assistants in the ED could identify these through direct observation, by report from the care team, or from sub sequence review of the medical record.

Additional Information

Francis X Guyette

University of Pittsburgh

Phone: 412 651 1077

Email: guyettef@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place