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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
Must not have
Any known history of renal or hepatic insufficiency/disease
Currently taking pain modifying medication(s)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours
Awards & highlights

Summary

This trial will test how sufentanil, a strong painkiller, affects conscious humans simulating blood loss. The study focuses on soldiers who need effective pain management without disrupting their body's ability to maintain blood pressure during injuries. The findings will help determine the best pain medication for soldiers with severe injuries. Sufentanil has been shown to be effective in managing acute pain in various clinical settings, including postoperative pain and cancer pain.

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.
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.
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
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of kidney or liver problems.
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I am currently on medication to manage pain.
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I am not within the specified age range for the trial.
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I am a current smoker or have smoked regularly in the last 3 years.
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I have heart, lung, brain, or metabolic conditions.
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I weigh less than 65 kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Tolerance to Simulated Hemorrhage
Secondary study objectives
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
~28870

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Sufentanil, an opioid analgesic, binds to mu-opioid receptors in the brain and spinal cord, inhibiting pain signal transmission and altering pain perception. This mechanism is crucial for healthy subjects in clinical trials to comprehend the potential effects, including pain relief and sedation, as well as risks like respiratory depression. This knowledge aids in developing safer and more effective pain management strategies.
Neurogenic inflammation as a novel treatment target for chronic pain syndromes.New and emerging treatments for vaso-occlusive pain in sickle cell disease.Pathophysiologic Approach to Pain Therapy for Complex Pain Entities: A Narrative Review.

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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
1,072 Previous Clinical Trials
1,056,216 Total Patients Enrolled
~13 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
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