Dexmedotomidine for Acute Pain Control in Patients With Multiple Rib FracturesRandomized Controll… (NCT05321121) | Clinical Trial Compass
CompletedPhase 4
Dexmedotomidine for Acute Pain Control in Patients With Multiple Rib FracturesRandomized Controlled Trial
United States41 participantsStarted 2021-11-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested dexmedetomidine specifically for acute pain from multiple rib fractures — is that the same situation I'm in, and does my injury pattern match the kind of patients who were enrolled?
2Since this was a Phase 4 randomized controlled trial that has already completed, has the results data been published, and what did it show about whether dexmedetomidine actually reduced morphine use compared to standard pain control?
3One of the main things this trial measured was how much morphine and morphine equivalents patients needed — based on the results, could dexmedetomidine realistically help reduce my opioid exposure during recovery, and does that matter for my specific situation?
4Dexmedetomidine is already an approved medication, but it's typically used in ICU or closely monitored settings — would using it for my rib fracture pain require hospitalization or intensive monitoring that might affect how my care is managed?
5Before considering something like dexmedetomidine, are there standard pain management approaches for multiple rib fractures — like a nerve block or epidural — that my care team would try first, and how do those compare to what this trial was testing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of Pain
Timeframe: Baseline through 48 hours after initiation of study medication, with pain scores recorded every 2 hours and summarized at 24 hours and 48 hours.
2
Use of Morphine and Morphine Equivalents.
Timeframe: through study completion of index hospitalization (up to 6 months)