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

  • End date
    Aug 31, 2023
  • participants needed
  • sponsor
    University of Texas Southwestern Medical Center
Updated on 25 April 2022
Accepts healthy volunteers


This study will examine how sufentanil (a commonly used pain medication) will alter responses to simulated blood loss in humans. To simulate blood loss in the research laboratory, participants will complete a test with their lower body in a custom-designed vacuum chamber for a brief period of time.


Pain management on the battlefield is critical for the wellbeing of the soldier. Given that a hemorrhagic injury on the battlefield is virtually always associated with pain, it is paramount that the selected pain medication does not disrupt appropriate physiological mechanisms that are beneficial towards the maintenance of blood pressure and vital organ blood flow during that hemorrhagic insult. Current guidelines for the selection of pain medications of a hemorrhaging soldier are based upon limited scientific evidence, with the vast majority of supporting studies being conducted on anesthetized animals. Thus, the interaction between hemorrhagic shock and pain medications commonly employed on the battlefield is yet to be determined in the conscious humans.

This study will test the hypothesis that sufentanil will impair the capacity for a conscious human to tolerate a hemorrhagic insult.

The obtained data will provide the necessary scientific evidence in humans to support the Committee on Tactical Combat Casualty Care (CoTCCC) guidelines on the analgesic of choice for moderate to severe injuries where the casualty is in hemorrhagic shock. Notably, such data will identify the analgesic that least compromises a human's ability to tolerate a hemorrhagic insult, ultimately providing critical information to the combat medic on which analgesic should be employed for such an injury.

Condition Healthy
Treatment Placebo, Sufentanil
Clinical Study IdentifierNCT04959812
SponsorUniversity of Texas Southwestern Medical Center
Last Modified on25 April 2022


Yes No Not Sure

Inclusion Criteria

-45 years of age
Non-obese (body mass index less than 30 kg/m2)
Body mass greater than or equal to 65 kg
Speak English

Exclusion Criteria

Subjects not in the defined age range
Subjects who have cardiac, respiratory, neurological and/or metabolic illnesses
Any known history of renal or hepatic insufficiency/disease
Pregnancy or breast feeding
Body mass less than 65 kg
Current smokers, as well as individuals who regularly smoked within the past 3 years
Subjects who cannot speak or read English
Positive urine drug screen
Currently taking pain modifying medication(s)
Clear my responses

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