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Opioid Analgesic

Sufentanil for Pain Management in Bleeding

Phase 1 & 2
Waitlist Available
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Non-obese (body mass index less than 30 kg/m2)
18-45 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Study Summary

This trial will study how well sufentanil works in reducing pain during simulated blood loss.

Who is the study for?
This trial is for healthy, English-speaking adults aged 18-45 with a body mass index (BMI) under 30 and weight over 65 kg. It's not for those with heart, lung, brain or metabolic diseases, kidney/liver problems, pregnant/breastfeeding women, smokers or recent ex-smokers within 3 years.Check my eligibility
What is being tested?
The study tests how sufentanil affects the body's response to simulated blood loss using a vacuum chamber that mimics this condition. Participants will either receive sufentanil or a placebo to compare outcomes.See study design
What are the potential side effects?
Sufentanil may cause typical opioid-related side effects such as nausea, dizziness, sedation, itching or respiratory depression. The extent of these side effects in the context of simulated blood loss will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My BMI is under 30.
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I am between 18 and 45 years old.
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My weight is at least 65 kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hemorrhage
Secondary outcome measures
Pain

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SufentanilExperimental Treatment1 Intervention
Sufentanil (30 microgram tablet) will be administered via a sublingual pill
Group II: PlaceboPlacebo Group1 Intervention
Placebo will be administered via a sublingual pill
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sufentanil
2013
Completed Phase 4
~28610

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,038 Previous Clinical Trials
1,046,742 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for new patients to join this research project?

"Yes, the trial is still open and recruiting patients. According to the information available on clinicaltrials.gov, the study was posted on March 1st, 2022 and last updated on November 8th, 2022. They are looking for 30 individuals to participate at 2 different sites."

Answered by AI

Are there any other existing studies that use Sufentanil?

"Right now, there are a total of 18 studies being conducted that involve Sufentanil. Out of those 18 studies, 5 are in Phase 3 clinical trials. The largest concentration of these research projects is located in Wuhan, Hubei; however, you can find these 26 different trial locations across the globe."

Answered by AI

Which types of patients does this study require?

"This study will allow up to 30 individuals aged 18-45 who currently have hs to participate. In order for an individual to be eligible, they must also meet the following additional requirements: They must speak English, have a body mass greater than or equal to 65 kg, and have a BMI less than 30kg/m2."

Answered by AI

In what ways has Sufentanil been found to be most effective?

"Sufentanil is often used to manage pain, but it can also be employed in the short-term treatment of general anesthesia, intubation (a medical procedure), and other conditions."

Answered by AI

How many patients are being enrolled in this research project?

"That is correct. The clinical trial, which was first posted on March 1st, 2022, is still recruiting patients. 30 participants are needed from 2 different sites according to the latest information available."

Answered by AI

Does this research project have an age limit?

"The age range for this particular trial is 18 to 45. There are a total of 112 trials for patients that are under the age of eighteen and 722 studies targeting senior citizens."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Mississippi
Texas
How old are they?
18 - 65
What site did they apply to?
Institute for Exercise and Environmental Medicine
University of Texas Southwestern Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I just love what I’m doing. It sounds like a good study and I would like to help advance treatment for those in need while being compensated.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Institute for Exercise and Environmental Medicine: < 24 hours
Average response time
  • < 1 Day
~5 spots leftby Aug 2024