Dexmedetomidine for Acute Pain from Rib Fractures

Overseen By Stephen Stopenski

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, Irvine

Must not be taking: Opioids

Disqualifiers: Pregnant, Prisoners, Dementia, others

Stay on Your Current Meds You can continue your current medications while participating

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 hours

41 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who are currently using more than 30mg of opioids per day.

What data supports the effectiveness of the drug Dexmedetomidine for acute pain from rib fractures?

Research shows that combining dexmedetomidine with bupivacaine in thoracic epidural analgesia can help control pain in patients with multiple rib fractures, suggesting its potential effectiveness in managing acute pain from rib fractures. ^{1 2 3 4 5}

Is dexmedetomidine (Precedex) safe for use in humans?

Dexmedetomidine (Precedex) is generally considered safe for use in humans, providing sedation and pain relief without causing breathing problems. However, it has been associated with some heart-related side effects, such as cardiac arrest in rare cases, and changes in blood pressure. ^{6 7 8 9 10}

How is the drug Dexmedetomidine unique for treating rib fracture pain?

Dexmedetomidine is unique because it can be used in combination with bupivacaine in a thoracic epidural to enhance pain relief for rib fractures, potentially reducing the need for opioids, which can cause respiratory issues, especially in older patients. ^{1 5 11 12 13}

Research Team

Jeffry Nahmias, MD

Principal Investigator

[e-mail]

Eligibility Criteria

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.

Inclusion Criteria

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

I have been admitted to the Intensive Care Unit.

Exclusion Criteria

Prisoners

I have severe liver disease.

Pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive an infusion of dexmedetomidine or normal saline for pain management

24 hours

Continuous monitoring in ICU

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain scores and respiratory complications

up to 6 months

Treatment Details

Interventions

• Dexmedetomidine
• Placebo

Trial Overview 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.

Participant Groups

Group I: Precedex arm Experimental Treatment 1 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 arm Placebo Group 1 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.

Dexmedetomidine is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Approved in United States as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Approved in Canada as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Approved in Japan as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Findings from Research

Dexmedetomidine is an alpha-2 adrenergic agonist that provides sedation and pain relief without causing respiratory depression, making it a safe option for patients requiring sedation.

In a case study, dexmedetomidine was effectively used as an adjuvant analgesic for a patient with cancer pain that did not respond to other treatments, highlighting its potential role in managing complex pain scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine as an adjuvant analgesic for intractable cancer pain. Roberts, SB., Wozencraft, CP., Coyne, PJ., et al.[2013]

Dexmedetomidine (DEX) is an effective sedative that provides anxiolysis and sedation without causing respiratory depression, making it suitable for use in pediatric intensive care.

In a case involving a three-year-old girl with a pacemaker, DEX administration led to unsuccessful atrial capture, suggesting that caution is needed when using DEX in patients with existing conduction abnormalities or those who are pacemaker-dependent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine-related atrial standstill and loss of capture in a pediatric patient after congenital heart surgery. Shepard, SM., Tejman-Yarden, S., Khanna, S., et al.[2013]

Dexmedetomidine is commonly used as a safe sedative during surgeries, but there are rare cases where it can lead to serious complications, such as cardiac arrest.

In this report, a 76-year-old woman experienced cardiac arrest during a pacemaker lead extraction procedure while being treated with dexmedetomidine, highlighting the need for careful monitoring in older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine related cardiac arrest in a patient with permanent pacemaker; a cautionary tale. Shah, AN., Koneru, J., Nicoara, A., et al.[2013]

Dexmedetomidine hydrochloride (Precedex) is a highly selective alpha(2)-adrenoreceptor agonist that effectively induces sedation and analgesia in ICU patients, with a significantly higher effective rate for reducing the need for additional sedatives (90.9% vs. 44.6% for placebo) and analgesics (87.3% vs. 75.0% for placebo).

The drug acts primarily through the alpha(2A)-receptor subtype in the locus coeruleus, leading to its sedative effects, but it can also cause adverse events such as hypertension and hypotension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dexmedetomidine hydrochloride (Precedex), a new sedative in intensive care, its pharmacological characteristics and clinical study result]. Taiji, K.[2019]

Dexmedetomidine is gaining popularity in pediatric care due to its strong safety and efficacy profile, particularly as an alternative to morphine for pain management in surgeries like craniosynostosis repair.

This study is the first to specifically evaluate the use of dexmedetomidine as a postoperative analgesic and sedative in children after craniosynostosis repair, highlighting a gap in existing research on its application in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Precedex in Post-Operative Pain Management Following Craniosynostosis Repair. Xu, H., Bui, A., Brown, S., et al.[2021]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

A Comparison of Continuous Thoracic Epidural Analgesia with Bupivacaine Versus Bupivacaine and Dexmedetomidine for Pain Control in Patients with Multiple Rib Fractures. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Posterior paramedian subrhomboidal analgesia versus thoracic epidural analgesia for pain control in patients with multiple rib fractures. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Epidural buprenorphine in management of pain in multiple rib fractures. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A double-blind, randomized controlled trial of gabapentin vs. placebo for acute pain management in critically ill patients with rib fractures. [2019]

5. Iran pubmed.ncbi.nlm.nih.gov

Comparison thoracic epidural and intercostal block to improve ventilation parameters and reduce pain in patients with multiple rib fractures. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Dexmedetomidine as an adjuvant analgesic for intractable cancer pain. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Dexmedetomidine-related atrial standstill and loss of capture in a pediatric patient after congenital heart surgery. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Dexmedetomidine related cardiac arrest in a patient with permanent pacemaker; a cautionary tale. [2013]

9. Japan pubmed.ncbi.nlm.nih.gov

[Dexmedetomidine hydrochloride (Precedex), a new sedative in intensive care, its pharmacological characteristics and clinical study result]. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

The Role of Precedex in Post-Operative Pain Management Following Craniosynostosis Repair. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Improving Opioid Prescribing Post-Discharge for Trauma Patients With Rib Fractures: Factors in Prevention of Prolonged Use and Dependency. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Assessment and management of rib fracture pain in geriatric population: an ode to old age. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Intercostal liposomal bupivacaine injection for rib fractures: A prospective randomized controlled trial. [2023]