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NCT05321121 · ClinicalTrials.gov registry record · Phase 4
Dexmedotomidine for Acute Pain Control in Patients With Multiple Rib FracturesRandomized Controlled Trial
A Phase 4 study, sponsored by University of California, Irvine.
- Completed
- Registry status
- Phase 4
- Development phase
- 41
- Enrollment target
NCT05321121: Completed Phase 4 study, sponsored by University of California, Irvine.
NCT05321121 is a Phase 4 study that has completed, run by University of California, Irvine. The registered enrollment target is 41 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05321121, a Phase 4 study, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 41 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- OTHER Placebo
- DRUG Dexmedetomidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2021-11-12 |
| Est. Completion | 2023-10-21 |
| Phase | Phase 4 |
What the finished NCT05321121 record still lists
NCT05321121 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05321121 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05321121 about?
NCT05321121 is a clinical study titled "Dexmedotomidine for Acute Pain Control in Patients With Multiple Rib FracturesRandomized Controlled Trial". 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 hospi...
What is the current status of trial NCT05321121?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 41 participants. The study started on 2021-11-12. Estimated completion is 2023-10-21.
What interventions are being tested in trial NCT05321121?
The interventions under investigation include: Placebo (OTHER), Dexmedetomidine (DRUG).
Who is sponsoring clinical trial NCT05321121?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05321121's enrollment target sits among peer trials
41 1390th of 2000 higher than 604 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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