What side effects are associated with this type of intervention?

Common side effects of opioid analgesics like sufentanil, which bind to mu-opioid receptors, include respiratory depression, constipation, nausea, vomiting, sedation, dizziness, and potential for dependence and abuse. These medications can also cause opioid-induced hyperalgesia, where increased sensitivity to pain occurs. In some cases, long-term use can lead to tolerance, requiring higher doses to achieve the same level of pain relief.

What prior FDA approvals exist?

The FDA has approved several opioid analgesics that bind to mu-opioid receptors for pain management. These include fentanyl, which is used for severe pain and is available in various forms such as transdermal patches and lozenges. Buprenorphine, another mu-opioid receptor agonist, is approved for both pain management and opioid addiction treatment. Methadone is also approved for chronic pain management and as part of opioid addiction treatment programs. These drugs, like sufentanil, are potent analgesics used in various clinical settings to manage moderate to severe pain.

What other types of research exist?

Promising alternatives to Sufentanil for pain management in healthy subjects include transdermal buprenorphine, which has shown efficacy and safety in chronic pain management, and cannabinoids like nabiximols, which have demonstrated analgesic effects in some studies. Non-opioid options such as ketorolac and ibuprofen are also effective for acute pain management.

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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 hours

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

0 / 9Eligibility criteria met

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.