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Dexmedotomidine for Acute Pain Control in Patients With Multiple Rib FracturesRandomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT05321121
Recruitment Status : Recruiting
First Posted : April 11, 2022
Last Update Posted : April 11, 2022
Sponsor:
Information provided by (Responsible Party):
Jeffrey Nahmias, University of California, Irvine

Brief Summary:

Blunt chest trauma is the second most common form of unintentional trauma in the US and is associated with significant morbidity and mortality. Thoracic injuries are the third most common cause of death in trauma patients. Rib fractures have an increased associated risk of pneumonia, prolonged hospitalization, and cost. The associated severe pain leads to poor pulmonary mechanics, which contributes to additional complications. Treatment for rib fractures is focused on optimizing analgesia and intense pulmonary hygiene. Most common strategies utilize early mobilization, incentive spirometry (IS), and multimodal pain regimens.

A variety of techniques for analgesia after blunt chest trauma exist. Epidural analgesia is one of the best-studied methods and can often provide significant pain relief. However, this method is invasive, has associated complications, and often can be contraindicated due to coagulopathy or other injuries. Most often a form of multimodal pain strategy is utilized which incorporates acetaminophen, Nonsteroidal anti-inflammatory drugs (NSAIDs), trans-dermal lidocaine, and muscle relaxants. Opioids remain an important adjunct to control severe pain, however, narcotics have their own associated complications.

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. The investigators hypothesize that dexmedetomidine will decrease patient pain and opioid use.


Condition or disease Intervention/treatment Phase
Rib Fractures Pain, Acute Drug: Dexmedetomidine Other: Placebo Phase 4

Detailed Description:

This is a prospective, randomized, double-blinded, placebo-controlled trial. Patients will be identified as they present to the trauma bay and meet eligibility criteria. Following informed consent patients will be randomized to either the intervention or control arm. Randomization and allocation concealment will be managed by a nominated independent individual(s) not involved in patient care or data extraction/analysis. The consenting physician will contact the randomization individual by phone. They will use a random number generator to assign group in a 1:1 ratio and then maintain a password-protected randomization database that is only accessible to the principal investigator and randomization individual(s).

The intervention arm will receive an infusion of dexmedetomidine (precedex) at 0.4-0.6 mcg/kg/h (Based off ideal body weight). 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. A pharmacist who does not participate in the rest of the study will encode the study drug accordingly. Dexmedetomidine is approved for ICU and procedural sedation, and its use in this study for analgesics is off-label. A baseline pain assessment will be performed using a numerical pain score (NPS). Infusions will start within 12 hours of arrival to the ICU and will continue for 24 hours. Infusion will stop once the patient is transferred out of the ICU or at 24 hours, whichever is first. In the scenario of possible adverse events (as listed below) the physician can hold or stop the study medication at their discretion. All enrolled patients will also receive a multimodal pain regimen with acetaminophen, NSAIDs, lidocaine patch, gabapentin, and muscle relaxants. For moderate and severe pain (5-10) patients will receive 5-10mg oxycodone every 4-6 hours upon request. Nursing staff will assess pain per the unit standard of care. NPS and opiate administration will be documented in the EMR by the nursing staff. All participants, providers, and staff will be blinded unless medical necessity requires patients to be unblinded.

Data will be collected prospectively from the EMR by blinded researchers and entered into a REDCap database. Data collection will include demographics, mechanism of injury, injury severity score (ISS), imaging, pain scores, pain medications, incentive spirometry, pulmonary complications, ICU LOS, hospital LOS, discharge disposition, and any other clinically relevant data.

Criteria for drop out include:

  • Participant withdrawal of consent
  • Ordered to drop-out by the investigators or attending physician
  • Cases of unmasked blinding

Since both injury severity and age can be confounding variables with pain, the study team plans to do a subgroup analysis after the completion of data collection. Injury severity Score (ISS) ≥ 15 and < 15 will be used to stratify injury severity. Age ≥ 65 and <65 will be used to stratify patient age.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a prospective, randomized, double-blinded, placebo-controlled trial. Patients will be identified as they present to the trauma bay and meet eligibility criteria. Following informed consent patients will be randomized to either the intervention or control arm. Randomization and allocation concealment will be managed by a nominated independent individual(s) not involved in patient care or data extraction/analysis. The consenting physician will contact the randomization individual by phone. They will use a random number generator to assign group in a 1:1 ratio and then maintain a password protected randomization database that is only accessible to the principal investigator and randomization individual(s).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Following informed consent patients will be randomized to either the intervention or control arm. Randomization and allocation concealment will be managed by a nominated independent individual(s) not involved in patient care or data extraction/analysis. The consenting physician will contact the randomization individual by phone. They will use a random number generator to assign group in a 1:1 ratio and then maintain a password protected randomization database that is only accessible to the principal investigator and randomization individual(s).

The intervention arm will receive an infusion of dexmedetomidine (precedex) at 0.4-0.6 mcg/kg/h (Based off ideal body weight). 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. A pharmacist who does not participate in the rest of the study will encode the study drug accordingly.

Primary Purpose: Treatment
Official Title: Dexmedotomidine for Acute Pain Control in Patients With Multiple Rib Fractures
Actual Study Start Date : March 14, 2022
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : June 30, 2024


Arm Intervention/treatment
Experimental: Precedex arm
The intervention arm will receive an infusion of dexmedetomidine (precedex) at 0.4-0.6 mcg/kg/h (Based off ideal body weight).
Drug: Dexmedetomidine
Dexmedotomidine for Acute Pain Control in Patients with Multiple Rib Fractures

Placebo Comparator: Control arm
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.
Other: Placebo
The control arm will receive an infusion of normal saline




Primary Outcome Measures :
  1. Evaluation of Pain [ Time Frame: through study completion of index hospitalization (up to 6 months) ]
    Numerical pain score (NPS): a score of 1-10 that will be recorded by the nurse in charge of the patients as standard of care.

  2. Use of morphine and morphine equivalents. [ Time Frame: through study completion of index hospitalization (up to 6 months) ]
    2. Oral morphine equivalents (OME) - A study team member will do a chart review and collect morphine used by the patients.


Secondary Outcome Measures :
  1. Epidural administration [ Time Frame: through study completion of index hospitalization (up to 6 months) ]
    Epidural use - patients that fail pain management will be offered an epidural

  2. Time in the hospital [ Time Frame: through study completion of index hospitalization (up to 6 months) ]
    ICU length of stay - number of days in the ICU Hospital length of stay - number of days admitted to the acute care hospital

  3. Respiratory complications [ Time Frame: through study completion of index hospitalization (up to 6 months) ]
    Respiratory complications - include events such as unplanned intubation, pneumonia, pneumothorax and incentive spirometry

  4. Mortality [ Time Frame: through study completion of index hospitalization (up to 6 months) ]
    Mortality - in-hospital mortality rate and 30-day mortality



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Blunt trauma patients
  • > 3 rib fractures
  • Admission to the ICU

Exclusion Criteria:

Exclusion criteria:

  • Younger than 18
  • Pregnant
  • Prisoners
  • History of adverse reaction to dexmedetomidine
  • GCS < 14
  • Acute CHF exacerbation
  • Bradycardia or heart block (HR <55)
  • Hypotension (SBP < 90mmHg or MAP < 65mmHg)
  • Current opioid use (>30mg OME/day)
  • Inability to communicate with staff (dementia)
  • Cirrhosis or chronic liver dysfunction (Child Pugh class C)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05321121


Contacts
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Contact: Jeffry Nahmias, MD 949-307-3035 jnahmias@hs.uci.edu
Contact: Stephen Stopenski 856-266-0784 sstopenski@hs.uci.edu

Locations
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United States, California
University of California, Irvine Recruiting
Orange, California, United States, 92868
Contact: Jeffry Nahmias, MD    949-307-3035    jnahmias@hs.uci.edu   
Sub-Investigator: Erika Tay Lasso, MD         
Sub-Investigator: Stephen Stopenski         
Sponsors and Collaborators
University of California, Irvine
Investigators
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Principal Investigator: Jeffry Nahmias, MD jnahmias@hs.uci.edu
Publications of Results:
Other Publications:
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Responsible Party: Jeffrey Nahmias, Associate Professor of Surgery, University of California, Irvine
ClinicalTrials.gov Identifier: NCT05321121    
Other Study ID Numbers: 20216525
First Posted: April 11, 2022    Key Record Dates
Last Update Posted: April 11, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jeffrey Nahmias, University of California, Irvine:
Rib Fracture
Pain
Dexmedotomidine
Additional relevant MeSH terms:
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Acute Pain
Fractures, Bone
Rib Fractures
Wounds and Injuries
Pain
Neurologic Manifestations
Thoracic Injuries
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action