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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05288348
Other study ID # STUDY21100180
Secondary ID W81XWH-16-D-0024
Status Completed
Phase Phase 3
First received
Last updated
Start date August 5, 2022
Est. completion date January 21, 2024

Study information

Verified date February 2024
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date January 21, 2024
Est. primary completion date January 21, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sufentanil 30 MCG Sublingual Tablet
30 microgram sublingual tablet administered using sublingual applicator
standard care pain treatment
standard care pain treatment given in Emergency Department

Locations

Country Name City State
United States University of Pittsburgh Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Frank Guyette United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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) 30 minutes after administration
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) every 30 minutes after administration until the time of ED discharge or rescue narcotic administered and up to 120 minutes after administration, whichever comes first
Secondary 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)
Secondary Richmond Agitation-Sedation Scale (RASS) every 30 minutes after administration until the time of ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration)
Secondary time-weighted Summed Pain Intensity Difference (SPID) every 30 minutes after administration until ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration)
Secondary Number of rescue narcotic doses at 30 minutes following administration and during ED stay (up to 120 minutes)
Secondary Time to reduction in VNRS pain score of 10 points determined by VNRS pain score (scale of 0-100, where 0 is having no pain) at 30 minutes following administration and every 30 minutes up to 120 minutes
Secondary Patient cognitive function as assessed by Six Item Screener (SIS) at 30 minutes following administration
Secondary Healthcare Professional Global Assessment (HPGA) of method of pain control at 30 minutes following administration
Secondary Acceptability of pain treatment to health care providers 5-point scale score of providers assessment of individual patient's pain management process, ease, and acceptability relative to past experience (scale of minus 2 to plus 2, where minus 2 is very dissatisfied and plus 2 is very satisfied) at 30 minutes following administration or when feasible
Secondary incidence of hypoxia needing supplemental oxygen SpO2 less than 90 percent from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Secondary incidence of hypotension systolic blood pressure less than 90mmHg from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Secondary advanced airway or bag mask ventilation from administration to ED discharge or rescue narcotic administration, whichever comes first (up to 120 minutes)
Secondary incidence of nausea from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Secondary incidence of vomiting from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Secondary incidence of headache from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Secondary incidence of dizziness from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
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