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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion of index hospitalization (up to 6 months)
Awards & highlights

Study Summary

This trial is studying whether using dexmedetomidine to manage pain in patients with 3 or more rib fractures is effective and safe.

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.Check my eligibility
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.See study design
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
Select...
I have more than three broken ribs from a blunt injury.
Select...
I have been admitted to the Intensive Care Unit.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluation of Pain
Use of morphine and morphine equivalents.
Secondary outcome measures
Epidural administration
Mortality
Respiratory complications
+1 more

Side effects data

From 2020 Phase 4 trial • 798 Patients • NCT02004613
57%
Clinically important hypotension
9%
Clinically important bradycardia
1%
infection
1%
stroke
1%
Atelectasis
1%
Hemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Dexmedetomidine

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

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor
536 Previous Clinical Trials
1,921,559 Total Patients Enrolled
Jeffry Nahmias, MDPrincipal Investigatorjnahmias@hs.uci.edu
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

Dexmedetomidine (Alpha-2 Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05321121 — Phase 4
Rib Fractures Research Study Groups: Precedex arm, Control arm
Rib Fractures Clinical Trial 2023: Dexmedetomidine Highlights & Side Effects. Trial Name: NCT05321121 — Phase 4
Dexmedetomidine (Alpha-2 Adrenergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05321121 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any new participants being admitted to this clinical trial at the present time?

"According to the clinicaltrials.gov database, this research project is currently enrolling participants. The investigation was initially submitted on March 14th 2022 and has since been revised as of April 7th 2022."

Answered by AI

Has the Food and Drug Administration sanctioned Dexmedetomidine?

"There is significant evidence indicating the safety of Dexmedetomidine, so it garnered a rating of 3 on our scale. This drug has officially been approved for medical use and can be found in Phase 4 clinical trials."

Answered by AI

How many participants are being enlisted in this medical trial?

"Affirmative. According to records compiled on clinicaltrials.gov, this medical study is currently seeking participants; it was first posted in March 14th 2022 and the most recent update occurred April 7th 2022. The requirement is for 60 individuals from a single site."

Answered by AI

What are the ultimate objectives of this clinical research?

"Over a period of 6 months, the primary objective this clinical trial is to assess pain levels. Secondary goals include assessing mortality rates both in-hospital and 30 days post hospitalisation, duration spent in ICU/Acute Care Hospital Units, and instances of respiratory complications such as pneumothorax or unplanned intubation."

Answered by AI
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~0 spots leftby Mar 2024