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

NCT05321121 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 20216525
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Rib Fractures; Pain, Acute

Keywords

Rib Fracture; Pain; Dexmedotomidine

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (4)

• Epidural Administration

  through study completion of index hospitalization (up to 6 months)

• Time in the Hospital

  through study completion of index hospitalization (up to 6 months)

• Respiratory Complications

  through study completion of index hospitalization (up to 6 months)

• Mortality

  through study completion of index hospitalization (up to 6 months)

Study Arms (2)

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).

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.

Other: Placebo

Interventions

Dexmedetomidine DRUG

Dexmedotomidine for Acute Pain Control in Patients with Multiple Rib Fractures

Precedex arm

Placebo OTHER

The control arm will receive an infusion of normal saline

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine

Orange, California, 92868, United States

Location

Related Publications (11)

• 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.

  PMID: 16269301 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.

  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.

  PMID: 30376537 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.

  PMID: 10866248 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.

  PMID: 15086666 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.

  PMID: 27533913 BACKGROUND

• 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.

  PMID: 19934395 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.

  PMID: 27812971 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.

  PMID: 29149140 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.

  PMID: 23706726 RESULT

• 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.

  PMID: 40900569 DERIVED

MeSH Terms

Conditions

Rib Fractures; Acute Pain; Pain

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Jeffry Nahmias
• Organization: University of California Irvine

jnahmias@hs.uci.edu

714-506-8076

Study Officials

• Jeffry Nahmias, MD

  jnahmias@hs.uci.edu

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Model Details: 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).

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: April 11, 2022
• Study Start: November 12, 2021
• Primary Completion: October 21, 2023
• Study Completion: October 21, 2023
• Last Updated: March 25, 2026
• Results First Posted: March 25, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)