Trial Outcomes & Findings for Evaluation of DEX-IN During Outpatient Procedures (NCT NCT03348423)
NCT ID: NCT03348423
Last Updated: 2023-05-25
Results Overview
Evaluation of subject reported pain intensity scores according to the 11-point Numeric Pain Rating Scale (NPRS; 0-10)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Up to 4 Hours
Results posted on
2023-05-25
Participant Flow
Participant milestones
| Measure |
DEX-IN 50 µg
Dexmedetomidine Intranasal Spray
DEX-IN: IN Dexmedetomidine + IV placebo
|
Fentanyl 50 µg
Intravenous Fentanyl
Fentanyl: IN Placebo + IV Fentanyl
|
Placebo
Placebo
Placebo: IN Placebo + IV Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of DEX-IN During Outpatient Procedures
Baseline characteristics by cohort
| Measure |
DEX-IN 50 µg
n=15 Participants
Dexmedetomidine Intranasal Spray
DEX-IN: IN Dexmedetomidine + IV placebo
|
Fentanyl 50 µg
n=15 Participants
Intravenous Fentanyl
Fentanyl: IN Placebo + IV Fentanyl
|
Placebo
n=15 Participants
Placebo
Placebo: IN Placebo + IV Placebo
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.5 years
STANDARD_DEVIATION 12.76 • n=99 Participants
|
47.2 years
STANDARD_DEVIATION 9.78 • n=107 Participants
|
46.8 years
STANDARD_DEVIATION 10.31 • n=206 Participants
|
44.5 years
STANDARD_DEVIATION 11.35 • n=157 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
40 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=157 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
40 Participants
n=157 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
15 participants
n=107 Participants
|
15 participants
n=206 Participants
|
45 participants
n=157 Participants
|
PRIMARY outcome
Timeframe: Up to 4 HoursPopulation: Randomized subjects
Evaluation of subject reported pain intensity scores according to the 11-point Numeric Pain Rating Scale (NPRS; 0-10)
Outcome measures
| Measure |
DEX-IN 50 µg
n=15 Participants
Dexmedetomidine Intranasal Spray
DEX-IN: IN Dexmedetomidine + IV placebo
|
Fentanyl 50 µg
n=15 Participants
Intravenous Fentanyl
Fentanyl: IN Placebo + IV Fentanyl
|
Placebo
n=15 Participants
Placebo
Placebo: IN Placebo + IV Placebo
|
|---|---|---|---|
|
Evaluation of Pain Intensity - Mean Pain Score During Procedure
|
3.03 units on a scale
Standard Deviation 0
|
3.10 units on a scale
Standard Deviation 0
|
4.25 units on a scale
Standard Deviation 0
|
Adverse Events
DEX-IN 50 µg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Fentanyl 50 µg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DEX-IN 50 µg
n=15 participants at risk
Dexmedetomidine Intranasal Spray
DEX-IN: IN Dexmedetomidine + IV placebo
|
Fentanyl 50 µg
n=15 participants at risk
Intravenous Fentanyl
Fentanyl: IN Placebo + IV Fentanyl
|
Placebo
n=15 participants at risk
Placebo
Placebo: IN Placebo + IV Placebo
|
|---|---|---|---|
|
Investigations
Blood pressure decrease
|
20.0%
3/15 • Number of events 4 • 7 Days
|
6.7%
1/15 • Number of events 1 • 7 Days
|
0.00%
0/15 • 7 Days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • 7 Days
|
6.7%
1/15 • Number of events 1 • 7 Days
|
0.00%
0/15 • 7 Days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
1/15 • Number of events 1 • 7 Days
|
0.00%
0/15 • 7 Days
|
0.00%
0/15 • 7 Days
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • Number of events 1 • 7 Days
|
6.7%
1/15 • Number of events 1 • 7 Days
|
0.00%
0/15 • 7 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Discussion and/or publication of data generated is not permitted without the prior written consent of the sponsor.
- Publication restrictions are in place
Restriction type: OTHER