Trial Outcomes & Findings for Dexmedotomidine for Acute Pain Control in Patients With Multiple Rib FracturesRandomized Controlled Trial (NCT NCT05321121)
NCT ID: NCT05321121
Last Updated: 2026-03-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
41 participants
Primary outcome 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.
Results posted on
2026-03-25
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
22
|
|
Overall Study
COMPLETED
|
19
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Precedex Arm
n=19 Participants
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
|
Control Arm
n=22 Participants
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
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=19 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=41 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=19 Participants
|
22 Participants
n=22 Participants
|
41 Participants
n=41 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=19 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=41 Participants
|
|
Age, Continuous
|
60.6 years
STANDARD_DEVIATION 14.8 • n=19 Participants
|
63.5 years
STANDARD_DEVIATION 17.6 • n=22 Participants
|
62.1 years
STANDARD_DEVIATION 16.3 • n=41 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=19 Participants
|
7 Participants
n=22 Participants
|
13 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=19 Participants
|
15 Participants
n=22 Participants
|
28 Participants
n=41 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
19 participants
n=19 Participants
|
22 participants
n=22 Participants
|
41 participants
n=41 Participants
|
PRIMARY outcome
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.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.
Outcome measures
| Measure |
Precedex Arm
n=19 Participants
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
|
Control Arm
n=22 Participants
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
|
|---|---|---|
|
Evaluation of Pain
|
4 score on a scale
Interval 1.0 to 10.0
|
4 score on a scale
Interval 1.0 to 8.0
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Precedex Arm
n=19 Participants
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
|
Control Arm
n=22 Participants
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
|
|---|---|---|
|
Use of Morphine and Morphine Equivalents.
|
125.5 Milligrams of morphine equivalents
Standard Deviation 137.1
|
87.1 Milligrams of morphine equivalents
Standard Deviation 131.0
|
SECONDARY outcome
Timeframe: through study completion of index hospitalization (up to 6 months)Epidural use - patients that fail pain management will be offered an epidural
Outcome measures
| Measure |
Precedex Arm
n=19 Participants
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
|
Control Arm
n=22 Participants
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
|
|---|---|---|
|
Epidural Administration
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: through study completion of index hospitalization (up to 6 months)ICU length of stay - number of days in the ICU Hospital length of stay - number of days admitted to the acute care hospital
Outcome measures
| Measure |
Precedex Arm
n=19 Participants
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
|
Control Arm
n=22 Participants
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
|
|---|---|---|
|
Time in the Hospital
ICU length of stay
|
4 Days
Interval 2.0 to 14.0
|
3 Days
Interval 2.0 to 15.0
|
|
Time in the Hospital
Hospital length of stay
|
10 Days
Interval 3.0 to 21.0
|
8 Days
Interval 3.0 to 47.0
|
SECONDARY outcome
Timeframe: through study completion of index hospitalization (up to 6 months)Respiratory complications - include events such as unplanned intubation, pneumonia, pneumothorax and incentive spirometry
Outcome measures
| Measure |
Precedex Arm
n=19 Participants
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
|
Control Arm
n=22 Participants
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
|
|---|---|---|
|
Respiratory Complications
Acute respiratory distress syndrome
|
3 Participants
|
3 Participants
|
|
Respiratory Complications
Pneumonia
|
2 Participants
|
1 Participants
|
|
Respiratory Complications
Unplanned intubation
|
3 Participants
|
2 Participants
|
|
Respiratory Complications
Pneumothorax
|
3 Participants
|
2 Participants
|
|
Respiratory Complications
Hemothorax
|
3 Participants
|
3 Participants
|
|
Respiratory Complications
Hemopneumothorax
|
6 Participants
|
8 Participants
|
|
Respiratory Complications
Incentive Spirometer < 50% predicted
|
15 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: through study completion of index hospitalization (up to 6 months)Mortality - in-hospital mortality rate and 30-day mortality
Outcome measures
| Measure |
Precedex Arm
n=19 Participants
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
|
Control Arm
n=22 Participants
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
|
|---|---|---|
|
Mortality
|
0 Participants
|
2 Participants
|
Adverse Events
Precedex Arm
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Control Arm
Serious events: 0 serious events
Other events: 4 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Precedex Arm
n=19 participants at risk
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
|
Control Arm
n=22 participants at risk
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
|
|---|---|---|
|
Blood and lymphatic system disorders
Hypotension
|
21.1%
4/19 • 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.
|
0.00%
0/22 • 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.
|
|
Cardiac disorders
Bradycardia
|
5.3%
1/19 • 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.
|
0.00%
0/22 • 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.
|
|
Social circumstances
Patient request
|
10.5%
2/19 • 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.
|
18.2%
4/22 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place