Rib FracturesPhase 4NCT05321121
Dexmedotomidine for Acute Pain Control in Patients With Multiple Rib FracturesRandomized Controlled Trial
A Phase 4 study testing Dexmedetomidine in people with Rib Fractures and Pain, Acute, run by University of California, Irvine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib Fractures, Pain, Acute
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2021to 21 Oct 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Blunt trauma patients
- > 3 rib fractures
- Admission to the ICU
Who cannot join
- Younger than 18
- Pregnant
- Prisoners
- History of adverse reaction to dexmedetomidine
- GCS < 14
- Acute CHF exacerbation
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine
Orange, California, 92868
About this study
Official title: Dexmedotomidine for Acute Pain Control in Patients With Multiple Rib Fractures
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.
Read the 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.
- Conditions
- Rib Fractures, Pain, Acute
- Being tested
- Dexmedetomidine, Placebo
- Keywords
- Rib Fracture, Pain, Dexmedotomidine
- Medical subject headings
- Rib Fractures, Acute Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedotomidine for Acute Pain Control in Patients with Multiple Rib Fractures
PlaceboOther
The control arm will receive an infusion of normal saline
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Dexmedetomidine |
| 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
- Oral morphine equivalents (OME) - A study team member will do a chart review and collect morphine used by the patients.
Measured: through study completion of index hospitalization (up to 6 months)
Secondary outcomes (4)
Epidural Administration
Epidural use - patients that fail pain management will be offered an epidural
Measured: through study completion of index hospitalization (up to 6 months)
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
Measured: 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
Measured: through study completion of index hospitalization (up to 6 months)
Mortality
Mortality - in-hospital mortality rate and 30-day mortality
Measured: through study completion of index hospitalization (up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start12 Nov 2021
- Primary completion21 Oct 2023
- Study completion21 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Rib FracturesStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffry Nahmias, MD, University of California, Irvine
- Investigators
- Jeffry Nahmias, MD, Principal investigator, jnahmias@hs.uci.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321121
- Sponsor's protocol ID
- 20216525
- Status last verified
- Nov 2025
- First submitted
- 14 Mar 2022
- Last updated
- 25 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16269301Lecky 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.
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.
PubMed 30376537Bulger 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.
PubMed 10866248Stawicki 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.
PubMed 15086666Galvagno 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.
PubMed 27533913Gerlach 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.
PubMed 19934395Zhang 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.
PubMed 27812971Peng 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.
PubMed 29149140Schnabel 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.
PubMed 23706726Nahmias 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.
PubMed 40900569
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedotomidine for Acute Pain Control in Patients With Multiple Rib Fractures
- ClinicalTrials.gov ID
- NCT05321121
- Acronym / sponsor ID
- 20216525
- Conditions
- Rib Fractures, Pain, Acute
- Keywords
- Rib Fracture, Pain, Dexmedotomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- 21 Oct 2023 (actual)
- Study completion
- 21 Oct 2023 (actual)
- First posted
- 11 Apr 2022 (actual)
- Results
- Posted 25 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Precedex arm | Experimental | Drug: DexmedetomidineThe 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 | Other: PlaceboThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Blunt trauma patients
- > 3 rib fractures
- Admission to the ICU
Key exclusion criteria (11 listed)
- Younger than 18
- Pregnant
- Prisoners
- History of adverse reaction to dexmedetomidine
- GCS < 14
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineDexmedotomidine for Acute Pain Control in Patients with Multiple Rib Fractures | Drug | Precedex arm |
| PlaceboThe control arm will receive an infusion of normal saline | Other | Control arm |
Primary outcome
Evaluation of Pain
Time frame: Baseline through 48 hours after initiation of study medication, with pain scores recorded every 2 hours and summarized at 24 hours and 48 hours.
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.
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.
4 secondary outcomes
Epidural Administration
Time frame: through study completion of index hospitalization (up to 6 months)
Time in the Hospital
Time frame: through study completion of index hospitalization (up to 6 months)
Respiratory Complications
Time frame: through study completion of index hospitalization (up to 6 months)
Mortality
Time frame: through study completion of index hospitalization (up to 6 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16269301Flagel 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.
- BackgroundLecky 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.
- Background: PubMed 30376537Carver 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.
- Background: PubMed 10866248Bulger 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.
- Background: PubMed 15086666Stawicki 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.
- Background: PubMed 27533913Galvagno 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.
- Results publication: PubMed 19934395Gerlach 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.
- Results publication: PubMed 27812971Zhang 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.
- Results publication: PubMed 29149140Peng 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.
- Results publication: PubMed 23706726Schnabel 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.
- Derived from this study: PubMed 40900569Nahmias 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffry Nahmias, MD principal investigator
jnahmias@hs.uci.edu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine in people with Rib Fractures and Pain, Acute, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Pain (time frame: Baseline through 48 hours after initiation of study medication, with pain scores recorded every 2 hours and summarized at 24 hours and 48 hours.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05321121, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.