Trial Outcomes & Findings for Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Morphine (NCT NCT04138615)

Last Updated: 2023-01-12

Results Overview

Tolerance to a simulated hemorrhagic challenge will be assessed, for both the placebo and morphine limbs, by causing progressive central hypovolemia via lower-body negative pressure (LBNP). This progressive 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 LBNP 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). A larger cumulative stress index represents a greater tolerance

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

44 participants

Primary outcome timeframe

30 minutes from the onset of applying lower-body negative pressure

Results posted on

2023-01-12

Participant Flow

Participant milestones

Participant milestones
Measure	Morphine First, Then Placebo Morphine will be administered first, followed by the Placebo (saline) visit.	Placebo First, Then Morphine Placebo visit (saline) first, then Morphine visit
Overall Study STARTED	19	25
Overall Study COMPLETED	14	16
Overall Study NOT COMPLETED	5	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=44 Participants These numbers are for all participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	29 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 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	3 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	44 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes from the onset of applying lower-body negative pressure

Outcome measures

Outcome measures
Measure	Morphine n=30 Participants Morphine will be administered intravenously Morphine: Subjects will receive Morphine while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.	Placebo n=30 Participants Saline will be administered intravenously Placebo: Subjects will receive saline while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.
Tolerance to Simulated Hemorrhage	385 CSI: Cumulative Stress Index Interval 251.0 to 728.0	692 CSI: Cumulative Stress Index Interval 473.0 to 997.0

SECONDARY outcome

Timeframe: 30 minutes from the onset of the protocol

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 morphine.

Outcome measures

Outcome measures
Measure	Morphine n=30 Participants Morphine will be administered intravenously Morphine: Subjects will receive Morphine while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.	Placebo n=30 Participants Saline will be administered intravenously Placebo: Subjects will receive saline while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.
Pain Assessment - Algometer	1.1 Kilogram force/0.13 cm^2 Interval 0.9 to 1.5	0.9 Kilogram force/0.13 cm^2 Interval 0.7 to 1.2

Adverse Events

Placebo Trial

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Morphine Trial

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

Dr Craig Crandall

University of Texas Southwestern Medical Center

Phone: 2143454623

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place