Trial Outcomes & Findings for Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Sufentanil (NCT NCT04959812)

Last Updated: 2025-06-26

Results Overview

Tolerance to a simulated hemorrhagic challenge will be assessed, for both the placebo and sufentanil limbs, by causing progressive central hypovolemia via lower-body negative pressure. This progressive lower-body negative pressure (LBNP) 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).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

46 participants

Primary outcome timeframe

6 hours

Results posted on

2025-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Then Sufentanil Participants received the placebo first followed by sufentanil.	Sufentanil Then Placebo Participants received the sufentanil first followed by placebo.
Overall Study STARTED	28	18
Overall Study COMPLETED	20	9
Overall Study NOT COMPLETED	8	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Sufentanil

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enrolled Participants in Crossover Design n=29 Participants Participants received both placebo and sufentanil in a randomized crossover model. Thus, the reported baseline characteristics reflect those individuals who participated in both limbs.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	29 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 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	2 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Body-Mass Index	25 kg/m^2 STANDARD_DEVIATION 2 • n=5 Participants

PRIMARY outcome

Timeframe: 6 hours

Outcome measures

Outcome measures
Measure	Sufentanil n=29 Participants Sufentanil (30 microgram tablet) will be administered via a sublingual pill Sufentanil: Subjects will receive Sufentanil while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.	Placebo n=29 Participants Placebo will be administered via a sublingual pill Placebo: Subjects will receive a placebo pill while the effects of this placebo on tolerance to a hemorrhagic insult will be assessed.
Tolerance to Simulated Hemorrhage	599 min*mmHg Standard Deviation 412	651 min*mmHg Standard Deviation 271

SECONDARY outcome

Timeframe: 6 hours

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 when the subject has received placebo and sufentanil.

Outcome measures

Outcome measures
Measure	Sufentanil n=29 Participants Sufentanil (30 microgram tablet) will be administered via a sublingual pill Sufentanil: Subjects will receive Sufentanil while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.	Placebo n=29 Participants Placebo will be administered via a sublingual pill Placebo: Subjects will receive a placebo pill while the effects of this placebo on tolerance to a hemorrhagic insult will be assessed.
Pain Assessment	1.04 kg Standard Deviation 0.43	1.16 kg Standard Deviation 0.40

Adverse Events

Sufentanil

Serious events: 0 serious events

Other events: 0 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

Adverse event data not reported

Additional Information

Craig Crandall

University of Texas Southwestern Medical Center

Phone: 214-345-4623

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place