What side effects are associated with this type of intervention?

Common treatments for rib fractures include multimodal pain regimens such as acetaminophen, NSAIDs, transdermal lidocaine, muscle relaxants, and opioids. Acetaminophen can cause liver damage if taken in high doses. NSAIDs may lead to gastrointestinal issues, kidney damage, and increased bleeding risk. Transdermal lidocaine can cause skin irritation and systemic toxicity if overused. Muscle relaxants often result in drowsiness and dizziness. Opioids, while effective for severe pain, carry risks of addiction, respiratory depression, and constipation. Dexmedetomidine, an alpha-2 adrenergic agonist, is being studied for its potential to reduce pain and opioid use. Its side effects include bradycardia, hypotension, and dry mouth.

What prior FDA approvals exist?

The FDA has approved various treatments for managing pain associated with rib fractures, primarily focusing on multimodal pain regimens. These include the use of acetaminophen, NSAIDs, transdermal lidocaine, and muscle relaxants. Opioids are also commonly used for severe pain management. Dexmedetomidine, an alpha-2 adrenergic agonist, is being studied for its potential to reduce pain and opioid use in patients with rib fractures, but it is not yet FDA-approved specifically for this indication.

What other types of research exist?

Promising alternatives to Dexmedetomidine for rib fracture pain management include: 1) Epidural analgesia, which provides significant pain relief but is invasive and may have contraindications. 2) Multimodal pain strategies incorporating acetaminophen, NSAIDs, transdermal lidocaine, and muscle relaxants. 3) Regional anesthesia techniques such as transversus abdominis plane (TAP) blocks and rectus sheath blocks, which are effective in postoperative pain management. 4) Gabapentin, which has been used in multimodal analgesic therapy to reduce postoperative pain and opioid consumption.

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Alpha-2 Adrenergic Agonist

Dexmedetomidine for Acute Pain from Rib Fractures

Phase 4

Waitlist Available

Led By Jeffry Nahmias, MD

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Blunt trauma patients with > 3 rib fractures

Admission to the ICU

Must not have

Cirrhosis or chronic liver dysfunction (Child Pugh class C)

Younger than 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion of index hospitalization (up to 6 months)

Awards & highlights

Pivotal Trial

All Individual Drugs Already Approved

Drug Has Already Been Approved

Summary

This trial aims to test if dexmedetomidine can help manage pain in patients with multiple rib fractures. The medication works by calming the nerves, which may reduce the need for stronger painkillers. Patients will receive either dexmedetomidine or another treatment to compare its effectiveness. Dexmedetomidine has been studied for its potential benefits in managing pain and sedation in various surgical and critical care settings.

Who is the study for?

This trial is for ICU patients with blunt trauma and at least 3 rib fractures. It's not for those under 18, pregnant, prisoners, or with acute heart failure, slow heart rate/heart block, high opioid use, dementia-like communication issues, very low blood pressure, severe liver dysfunction (Child Pugh class C), or a bad reaction to dexmedetomidine.

What is being tested?

The study tests if dexmedetomidine can help manage pain better than a placebo in patients with multiple rib fractures from chest trauma. The goal is to see if it reduces pain and the need for opioids.

What are the potential side effects?

Dexmedetomidine may cause side effects like low blood pressure (hypotension), slow heart rate (bradycardia), dry mouth or nausea. These are common but vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have more than three broken ribs from a blunt injury.

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I have been admitted to the Intensive Care Unit.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe liver disease.

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I am under 18 years old.

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I can communicate clearly without any issues.

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I am currently experiencing a worsening of my heart failure symptoms.

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My consciousness level is somewhat impaired.

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I am currently taking more than 30mg of opioids daily.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion of index hospitalization (up to 6 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion of index hospitalization (up to 6 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion of index hospitalization (up to 6 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluation of Pain

Use of morphine and morphine equivalents.

Secondary study objectives

Epidural administration

Mortality

Respiratory complications

+1 more

Side effects data

From 2020 Phase 4 trial • 798 Patients • NCT02004613

57%

Clinically important hypotension

Clinically important bradycardia

infection

stroke

Atelectasis

Hemorrhage

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Dexmedetomidine

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Precedex armExperimental Treatment1 Intervention

The intervention arm will receive an infusion of dexmedetomidine (precedex) at 0.4-0.6 mcg/kg/h (Based off ideal body weight).

Group II: Control armPlacebo Group1 Intervention

The control arm will receive an infusion of normal saline. Medication distribution and management will be handled by the Investigational Drug Service (IDS) at UCI medical center.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexmedetomidine

FDA approved

0 / 8Eligibility 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

The most common treatments for rib fractures focus on optimizing pain management to improve pulmonary mechanics and reduce complications such as pneumonia. Dexmedetomidine, an alpha-2 adrenergic agonist, works by activating alpha-2 receptors in the central nervous system, leading to sedation, anxiolysis, and analgesia. This is particularly important for rib fracture patients as effective pain control allows for better breathing, coughing, and mobilization, which are crucial for preventing respiratory complications. Other common analgesic strategies include multimodal pain regimens that combine acetaminophen, NSAIDs, transdermal lidocaine, and muscle relaxants, with opioids used as adjuncts for severe pain. These treatments collectively aim to reduce pain, enhance patient comfort, and promote faster recovery.

Effect of Continuous Paravertebral Dexmedetomidine Administration on Intraoperative Anesthetic Drug Requirement and Post-Thoracotomy Pain Syndrome After Thoracotomy: A Randomized Controlled Trial.