Sufentanil 30 MCG Sublingual Tablet for Traumatic Injury

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
University of Pittsburgh, Pittsburgh, PATraumatic InjurySufentanil 30 MCG Sublingual Tablet - Drug
Eligibility
18 - 70
All Sexes
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Study Summary

This trial looks at whether giving sufentanil to patients in the emergency department for pain relief works better than standard care.

Eligible Conditions
  • Traumatic Injury

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

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Study Objectives

0 Primary · 16 Secondary · Reporting Duration: at 30 minutes following administration and every 30 minutes up to 120 minutes

at 30 minutes following administration
Healthcare Professional Global Assessment (HPGA) of method of pain control
Patient cognitive function as assessed by Six Item Screener (SIS)
at 30 minutes following administration and during ED stay (up to 120 minutes)
Number of rescue narcotic doses
at 30 minutes following administration and every 30 minutes up to 120 minutes
Time to reduction in VNRS pain score of 10 points
at 30 minutes following administration or when feasible
Pain
every 30 minutes after administration until ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration)
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
Verbally administered Numeric Rating Scale (VNRS)
every 30 minutes after administration until the time of ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration)
Patient Global Assessment (PGA) of Pain Control
Richmond Agitation-Sedation Scale (RASS)
from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
incidence of dizziness
incidence of headache
incidence of hypotension
incidence of hypoxia needing supplemental oxygen
incidence of nausea
Vomiting
from administration to ED discharge or rescue narcotic administration, whichever comes first (up to 120 minutes)
advanced airway or bag mask ventilation

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

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426c.Mod.Core-C4b 100 mcg
1
Tobacco product administration and assessment
1
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Trial Design

2 Treatment Groups

Standard Care
1 of 2
DSUVIA (sufentanil)
1 of 2

Active Control

Experimental Treatment

150 Total Participants · 2 Treatment Groups

Primary Treatment: Sufentanil 30 MCG Sublingual Tablet · No Placebo Group · Phase 3

DSUVIA (sufentanil)
Drug
Experimental Group · 1 Intervention: Sufentanil 30 MCG Sublingual Tablet · Intervention Types: Drug
Standard Care
Drug
ActiveComparator Group · 1 Intervention: standard care pain treatment · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 30 minutes following administration and every 30 minutes up to 120 minutes

Who is running the clinical trial?

United States Department of DefenseFED
792 Previous Clinical Trials
213,143 Total Patients Enrolled
Frank GuyetteLead Sponsor
Jason Sperry, MDStudy DirectorUniversity of Pittsburgh
2 Previous Clinical Trials
1,630 Total Patients Enrolled

Eligibility Criteria

Age 18 - 70 · All Participants · 4 Total Inclusion Criteria

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References

Frequently Asked Questions

Are there any more slots available for volunteers in this experiment?

"Yes, as of 8/23/2022 this study is looking for patients to enroll. The first posting was on 8/5/2022." - Anonymous Online Contributor

Unverified Answer

What is the uppermost limit to how many people can be a part of this test simultaneously?

"That is correct. The information provided on clinicaltrials.gov does show that the study is still recruiting patients. 150 participants are needed in total, and recruitment will take place at a single site." - Anonymous Online Contributor

Unverified Answer

Are people of age for this trial being accepted?

"This study includes all patients that are aged 18-70, as specified in the enrollment requirements." - Anonymous Online Contributor

Unverified Answer

What are the risks associated with taking Sufentanil 30 MCG Sublingual Tablet?

"Given that this is a Phase 3 trial with some data supporting efficacy as well as multiple rounds of data affirming safety, our team at Power has given Sufentanil 30 MCG Sublingual Tablet a score of 3 for safety." - Anonymous Online Contributor

Unverified Answer

Which type of patient would be the best fit for this trial?

"This study is seeking to enroll 150 individuals who have recently experienced a traumatic injury and are aged between 18-70. The most important requirements for participants are: that they must be trauma patients (Level I, II or III), in need of pain treatment as indicated by an NRS score of ≥ 50, and have been in the Emergency Department for more than 30 minutes following informed consent." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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