Pain
Conditions
Keywords
Peri-procedural pain, Pain, Anxiety, Analgesia, Anxiolysis
Brief summary
The primary objective of this study is to evaluate the analgesic efficacy of DEX-IN compared with placebo and active control (fentanyl), in subjects undergoing painful outpatient and office based procedures.
Interventions
DRUGDEX-IN
IN Dexmedetomidine + IV placebo
DRUGFentanyl
IN Placebo + IV Fentanyl
DRUGPlacebo
IN Placebo + IV Placebo
Sponsors
Baudax Bio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind, double-dummy
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Voluntarily provide written informed consent * Be planned to undergo a selected office-based or outpatient procedure * Be naïve to the planned procedure, i.e. no repeated or revision procedures * Not pregnant or planning to become pregnant, or using appropriate contraceptive measures.
Exclusion criteria
* Known allergy to any study treatment or excipient * Have another painful physical condition or anxiety related diagnosis that may confound study assessments * Evidence of a clinically significant finding on physical examination, laboratory assessment, or ECG * Have signs or a history of significant nasal condition that may interfere with intranasal drug delivery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Pain Intensity - Mean Pain Score During Procedure | Up to 4 Hours | Evaluation of subject reported pain intensity scores according to the 11-point Numeric Pain Rating Scale (NPRS; 0-10) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DEX-IN 50 µg Dexmedetomidine Intranasal Spray
DEX-IN: IN Dexmedetomidine + IV placebo | 15 |
| Fentanyl 50 µg Intravenous Fentanyl
Fentanyl: IN Placebo + IV Fentanyl | 15 |
| Placebo Placebo
Placebo: IN Placebo + IV Placebo | 15 |
| Total | 45 |
Baseline characteristics
| Characteristic | DEX-IN 50 µg | Total | Placebo | Fentanyl 50 µg |
|---|---|---|---|---|
| Age, Continuous | 39.5 years STANDARD_DEVIATION 12.76 | 44.5 years STANDARD_DEVIATION 11.35 | 46.8 years STANDARD_DEVIATION 10.31 | 47.2 years STANDARD_DEVIATION 9.78 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 40 Participants | 13 Participants | 15 Participants |
| Region of Enrollment United States | 15 participants | 45 participants | 15 participants | 15 participants |
| Sex: Female, Male Female | 13 Participants | 40 Participants | 14 Participants | 13 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 5 / 15 | 2 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 |
Outcome results
Primary
Evaluation of Pain Intensity - Mean Pain Score During Procedure
Evaluation of subject reported pain intensity scores according to the 11-point Numeric Pain Rating Scale (NPRS; 0-10)
Time frame: Up to 4 Hours
Population: Randomized subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DEX-IN 50 µg | Evaluation of Pain Intensity - Mean Pain Score During Procedure | 3.03 units on a scale | Standard Deviation 0 |
| Fentanyl 50 µg | Evaluation of Pain Intensity - Mean Pain Score During Procedure | 3.10 units on a scale | Standard Deviation 0 |
| Placebo | Evaluation of Pain Intensity - Mean Pain Score During Procedure | 4.25 units on a scale | Standard Deviation 0 |