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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests dexmedetomidine to determine if it manages severe pain from rib fractures and reduces opioid use. Rib fractures can cause intense pain and lead to complications like pneumonia. The trial includes patients admitted to the ICU with blunt trauma and three or more rib fractures. Participants will receive either dexmedetomidine (a sedative and pain relief medication) or a placebo to compare effects. The study aims to find a safer and more effective pain management strategy for serious rib injuries. As a Phase 4 trial, this research examines how an FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for dexmedetomidine?

Research has shown that dexmedetomidine is generally safe for people. It aids in sedation and pain relief without causing breathing issues. Some studies found that it can help manage vital signs in patients with severe pain after surgery. Although it is safe, its ability to improve pain control or reduce the need for opioids in rib fracture cases is limited. Overall, dexmedetomidine is well-tolerated, and previous research has not reported any major safety concerns. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about dexmedetomidine for acute pain from rib fractures because it offers a unique approach compared to typical pain treatments like opioids or NSAIDs. Unlike these standard treatments, dexmedetomidine works by targeting specific receptors in the brain, providing pain relief and sedation without the risk of respiratory depression common with opioids. This makes it a promising alternative for managing pain in a potentially safer way. Additionally, its use as an infusion allows for precise control over dosing, which can be adjusted based on the patient's needs.

What evidence suggests that dexmedetomidine might be an effective treatment for acute pain from rib fractures?

In this trial, participants will join one of two arms to evaluate the effectiveness of dexmedetomidine for managing acute pain from rib fractures. Research has shown that dexmedetomidine, a drug sometimes used during surgery, might aid recovery and reduce long-term pain. It calms the nerves, potentially helping manage pain from broken ribs. However, some studies found it does not significantly lower pain levels or reduce the need for painkillers in patients with rib fractures who are not using a breathing tube. Thus, its effectiveness for rib fracture pain remains uncertain. While there is hope for its benefits, more research is needed to confirm its role in managing sudden pain from rib fractures. ^{1 2 4 5 6}

Who Is on the Research Team?

Jeffry Nahmias, MD

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05321121

Dexmedotomidine for Acute Pain Control in Patients With ... The aim of our study is to use an infusion of dexmedetomidine (Precedex) to aid in pain management in patients presenting with 3 or more rib fractures.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40900569/

Dexmedetomidine for Analgesia in Nonintubated Patients ... Conclusions and relevance: Adjunctive dexmedetomidine did not reduce opioid consumption, improve pain scores, or lower pulmonary complication ...

3. clinicalpainadvisor.com clinicalpainadvisor.com/news/dexmedetomidine-ineffective-rib-fracture-pain/

Adjunctive Dexmedetomidine Does Not Improve Pain or ... A recent clinical trial found that adjunctive dexmedetomidine didn't significantly improve pain scores or reduce opioid consumption in ICU ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0007091224003465

Effectiveness of dexmedetomidine on patient-centred ... Intraoperative dexmedetomidine likely results in meaningful improvement in the quality of recovery and chronic pain after surgery.

5. withpower.com withpower.com/trial/phase-4-acute-pain-2-2022-b4630

Dexmedetomidine for Acute Pain from Rib Fractures This trial aims to test if dexmedetomidine can help manage pain in patients with multiple rib fractures. The medication works by calming the nerves, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12240532/

A randomized controlled clinical trial to investigate the efficacy ... Conclusions: Dexmedetomidine could effectively manage the vital signs of patients with postoperative acute pain, improve treatment outcomes, ...