Trial Outcomes & Findings for Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Fentanyl (NCT NCT04136548)
NCT ID: NCT04136548
Last Updated: 2022-01-24
Results Overview
Tolerance to a simulated hemorrhagic challenge will be assessed, for both the placebo and fentanyl limbs, by causing progressive central hypovolemia via lower-body negative pressure (LBNP). This progressive lower-body negative pressure challenge will be performed until the onset of syncopal symptoms (defined as: profound bradycardia, a precipitous drop in arterial blood pressure and accompanying narrowing of pulse pressure, a sustained systolic blood pressure less than 80 mmHg, and/or subjective symptoms such as light-headedness, sweating, nausea, or dizziness). The primary variable will be the quantification of lower-body negative pressure that is required to cause these symptoms. This quantification will be objectively measured via a cumulative stress index which is calculated as the sum of the product of the LBNP level and the duration of each level, until test termination (i.e., 40 mmHg x 3 min + 50 mmHg x 3 min, etc).
COMPLETED
PHASE1/PHASE2
41 participants
12 months
2022-01-24
Participant Flow
Forty-one adults enrolled by providing written and oral consent. Of these 38, three adults were deemed not to be eligible based upon screening criteria prior to randomization. Therefore, only 38 adults were 'enrolled and randomized' (see 'Participant Flow' below).
Participant milestones
| Measure |
Placebo, Then Fentanyl
Participants first received Placebo (75 ug) each (\<5mins). After a washout period of lying down for resting for sometime , then Fentanyl (75 ug) is administered to each participant (\<5 mins)
|
Fentanyl, Then Placebo
Participants first received Fentanyl (75 ug) visit. each (\<5mins). After a washout period of lying down for resting for sometime , then Placebo (75 ug) is administered to each participant (\<5 mins)
|
|---|---|---|
|
Enrolled & Randomized
STARTED
|
19
|
19
|
|
Enrolled & Randomized
COMPLETED
|
13
|
15
|
|
Enrolled & Randomized
NOT COMPLETED
|
6
|
4
|
|
First Visit
STARTED
|
13
|
15
|
|
First Visit
COMPLETED
|
13
|
15
|
|
First Visit
NOT COMPLETED
|
0
|
0
|
|
Washout (at Least 48 Hours)
STARTED
|
13
|
15
|
|
Washout (at Least 48 Hours)
COMPLETED
|
13
|
15
|
|
Washout (at Least 48 Hours)
NOT COMPLETED
|
0
|
0
|
|
Second Visit
STARTED
|
13
|
15
|
|
Second Visit
COMPLETED
|
13
|
15
|
|
Second Visit
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Fentanyl
Baseline characteristics by cohort
| Measure |
All Participants
n=41 Participants
All participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsTolerance to a simulated hemorrhagic challenge will be assessed, for both the placebo and fentanyl limbs, by causing progressive central hypovolemia via lower-body negative pressure (LBNP). This progressive lower-body negative pressure challenge will be performed until the onset of syncopal symptoms (defined as: profound bradycardia, a precipitous drop in arterial blood pressure and accompanying narrowing of pulse pressure, a sustained systolic blood pressure less than 80 mmHg, and/or subjective symptoms such as light-headedness, sweating, nausea, or dizziness). The primary variable will be the quantification of lower-body negative pressure that is required to cause these symptoms. This quantification will be objectively measured via a cumulative stress index which is calculated as the sum of the product of the LBNP level and the duration of each level, until test termination (i.e., 40 mmHg x 3 min + 50 mmHg x 3 min, etc).
Outcome measures
| Measure |
Fentanyl
n=28 Participants
Fentanyl will be administered intravenously during one visit.
Fentanyl: Subjects will receive 75 ug Fentanyl while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.
|
Placebo
n=28 Participants
Placebo (saline) will be administered intravenously during one visit.
Placebo: Subjects will receive saline while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.
|
|---|---|---|
|
Cumulative Stress Index
|
647 mmHg x minutes
Standard Deviation 386
|
676 mmHg x minutes
Standard Deviation 295
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Pressure pain tolerance was evaluated in a subset of individuals
Pain assessments will be conducted using a digital algometer to obtain maximum pain thresholds caused by pressure. This pain assessment technique is conducted by applying the tip of a hand-held digital algometer on the subject's digit. Force is gradually increased and the peak force is recorded when the subject first reports a painful sensation. Removal of the pressure from the algometer immediately relieves the painful sensation and the subject can voluntarily stop the test at any time. This assessment will be performed after the subject has received placebo and fentanyl.
Outcome measures
| Measure |
Fentanyl
n=17 Participants
Fentanyl will be administered intravenously during one visit.
Fentanyl: Subjects will receive 75 ug Fentanyl while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.
|
Placebo
n=17 Participants
Placebo (saline) will be administered intravenously during one visit.
Placebo: Subjects will receive saline while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.
|
|---|---|---|
|
Pressure Pain Tolerance
|
1.6 Kilograms
Interval 0.9 to 2.2
|
1.1 Kilograms
Interval 0.8 to 1.3
|
Adverse Events
Placebo
Fentanyl
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Craig Crandall
University of Texas Southwestern Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place