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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.
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Precedex arm | Experimental | The intervention arm will receive an infusion of dexmedetomidine (precedex) at 0.4-0.6 mcg/kg/h (Based off ideal body weight). |
|
| Control arm | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Dexmedotomidine for Acute Pain Control in Patients with Multiple Rib Fractures |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Pain | Numerical pain score (NPS): an 11-point pain rating scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain severity (worse outcome). Pain scores were recorded by nursing staff every 2 hours beginning immediately prior to initiation of the study medication and continued for up to 48 hours. The primary outcome evaluated pain scores over the 48-hour study period. | Baseline through 48 hours after initiation of study medication, with pain scores recorded every 2 hours and summarized at 24 hours and 48 hours. |
| Use of Morphine and Morphine Equivalents. | 2. Oral morphine equivalents (OME) - A study team member will do a chart review and collect morphine used by the patients. | through study completion of index hospitalization (up to 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Epidural Administration | Epidural use - patients that fail pain management will be offered an epidural | through study completion of index hospitalization (up to 6 months) |
| Time in the Hospital |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffry Nahmias, MD | jnahmias@hs.uci.edu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine | Orange | California | 92868 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16269301 | Background | Flagel BT, Luchette FA, Reed RL, Esposito TJ, Davis KA, Santaniello JM, Gamelli RL. Half-a-dozen ribs: the breakpoint for mortality. Surgery. 2005 Oct;138(4):717-23; discussion 723-5. doi: 10.1016/j.surg.2005.07.022. | |
| Background | Lecky FE, Bouamra O, Woodford M, Alexandrescu R, O'Brien SJ. Epidemiology of Polytrauma. In: Damage Control Management in the Polytrauma Patient. New York, NY: Springer New York; 2010:13-24. | ||
| 30376537 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). Dexmedetomidine: Dexmedotomidine for Acute Pain Control in Patients with Multiple Rib Fractures |
| FG001 | 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. Placebo: The control arm will receive an infusion of normal saline |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). Dexmedetomidine: Dexmedotomidine for Acute Pain Control in Patients with Multiple Rib Fractures |
| BG001 | Control Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evaluation of Pain | Numerical pain score (NPS): an 11-point pain rating scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain severity (worse outcome). Pain scores were recorded by nursing staff every 2 hours beginning immediately prior to initiation of the study medication and continued for up to 48 hours. The primary outcome evaluated pain scores over the 48-hour study period. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline through 48 hours after initiation of study medication, with pain scores recorded every 2 hours and summarized at 24 hours and 48 hours. |
|
From initiation of study medication through 48 hours (end of study infusion period) or until transfer out of the ICU, whichever occurred first.
Adverse events were monitored and recorded for all participants during the study treatment period and throughout hospitalization.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). Dexmedetomidine: Dexmedotomidine for Acute Pain Control in Patients with Multiple Rib Fractures |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffry Nahmias | University of California Irvine | 714-506-8076 | jnahmias@hs.uci.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 24, 2021 | Mar 5, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 5, 2023 | Mar 5, 2026 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D012253 | Rib Fractures |
| D059787 | Acute Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D013898 | Thoracic Injuries |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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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).
Not provided
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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.
| Placebo | Other | The control arm will receive an infusion of normal saline |
|
ICU length of stay - number of days in the ICU Hospital length of stay - number of days admitted to the acute care hospital
| through study completion of index hospitalization (up to 6 months) |
| Respiratory Complications | Respiratory complications - include events such as unplanned intubation, pneumonia, pneumothorax and incentive spirometry | through study completion of index hospitalization (up to 6 months) |
| Mortality | Mortality - in-hospital mortality rate and 30-day mortality | through study completion of index hospitalization (up to 6 months) |
| Background |
| Carver TW, Kugler NW, Juul J, Peppard WJ, Drescher KM, Somberg LB, Szabo A, Yin Z, Paul JS. Ketamine infusion for pain control in adult patients with multiple rib fractures: Results of a randomized control trial. J Trauma Acute Care Surg. 2019 Feb;86(2):181-188. doi: 10.1097/TA.0000000000002103. |
| 10866248 | Background | Bulger EM, Arneson MA, Mock CN, Jurkovich GJ. Rib fractures in the elderly. J Trauma. 2000 Jun;48(6):1040-6; discussion 1046-7. doi: 10.1097/00005373-200006000-00007. |
| 15086666 | Background | Stawicki SP, Grossman MD, Hoey BA, Miller DL, Reed JF 3rd. Rib fractures in the elderly: a marker of injury severity. J Am Geriatr Soc. 2004 May;52(5):805-8. doi: 10.1111/j.1532-5415.2004.52223.x. |
| 27533913 | Background | Galvagno SM Jr, Smith CE, Varon AJ, Hasenboehler EA, Sultan S, Shaefer G, To KB, Fox AD, Alley DE, Ditillo M, Joseph BA, Robinson BR, Haut ER. Pain management for blunt thoracic trauma: A joint practice management guideline from the Eastern Association for the Surgery of Trauma and Trauma Anesthesiology Society. J Trauma Acute Care Surg. 2016 Nov;81(5):936-951. doi: 10.1097/TA.0000000000001209. |
| 19934395 | Result | Gerlach AT, Murphy CV, Dasta JF. An updated focused review of dexmedetomidine in adults. Ann Pharmacother. 2009 Dec;43(12):2064-74. doi: 10.1345/aph.1M310. |
| 27812971 | Result | Zhang X, Wang D, Shi M, Luo Y. Efficacy and Safety of Dexmedetomidine as an Adjuvant in Epidural Analgesia and Anesthesia: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Clin Drug Investig. 2017 Apr;37(4):343-354. doi: 10.1007/s40261-016-0477-9. |
| 29149140 | Result | Peng K, Zhang J, Meng XW, Liu HY, Ji FH. Optimization of Postoperative Intravenous Patient-Controlled Analgesia with Opioid-Dexmedetomidine Combinations: An Updated Meta-Analysis with Trial Sequential Analysis of Randomized Controlled Trials. Pain Physician. 2017 Nov;20(7):569-596. |
| 23706726 | Result | Schnabel A, Meyer-Friessem CH, Reichl SU, Zahn PK, Pogatzki-Zahn EM. Is intraoperative dexmedetomidine a new option for postoperative pain treatment? A meta-analysis of randomized controlled trials. Pain. 2013 Jul;154(7):1140-9. doi: 10.1016/j.pain.2013.03.029. Epub 2013 Mar 27. |
| 40900569 | Derived | Nahmias J, Stopenski S, Jebbia M, Atallah S, Kirby KA, Alvarez CA, Aryan N, Tay-Lasso E, Dolich M, Lekawa M, Swentek L, Santos J, Schubl S, Kuza C, Nguyen N, Grigorian A. Dexmedetomidine for Analgesia in Nonintubated Patients With Traumatic Rib Fractures: A Randomized Clinical Trial. JAMA Surg. 2025 Oct 1;160(10):1047-1056. doi: 10.1001/jamasurg.2025.3221. |
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. Placebo: The control arm will receive an infusion of normal saline |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. Placebo: The control arm will receive an infusion of normal saline |
|
|
| Primary | Use of Morphine and Morphine Equivalents. | 2. Oral morphine equivalents (OME) - A study team member will do a chart review and collect morphine used by the patients. | Posted | Mean | Standard Deviation | Milligrams of morphine equivalents | through study completion of index hospitalization (up to 6 months) |
|
|
|
| Secondary | Epidural Administration | Epidural use - patients that fail pain management will be offered an epidural | Posted | Count of Participants | Participants | through study completion of index hospitalization (up to 6 months) |
|
|
|
| Secondary | Time in the Hospital | ICU length of stay - number of days in the ICU Hospital length of stay - number of days admitted to the acute care hospital | Posted | Median | Inter-Quartile Range | Days | through study completion of index hospitalization (up to 6 months) |
|
|
|
| Secondary | Respiratory Complications | Respiratory complications - include events such as unplanned intubation, pneumonia, pneumothorax and incentive spirometry | Posted | Count of Participants | Participants | through study completion of index hospitalization (up to 6 months) |
|
|
|
| Secondary | Mortality | Mortality - in-hospital mortality rate and 30-day mortality | Posted | Count of Participants | Participants | through study completion of index hospitalization (up to 6 months) |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 7 |
| 19 |
| EG001 | 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. Placebo: The control arm will receive an infusion of normal saline | 2 | 22 | 0 | 22 | 4 | 22 |
| Bradycardia | Cardiac disorders | Non-systematic Assessment |
|
| Patient request | Social circumstances | Non-systematic Assessment |
|
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Unplanned intubation |
|
| Pneumothorax |
|
| Hemothorax |
|
| Hemopneumothorax |
|
| Incentive Spirometer < 50% predicted |
|